Sponsor has been issued a PREA non-compliance letter on 7/17/13.
Zegerid® (Omeprazole and Sodium Bicarbonate)
Per FDA letter dated 05/11/2016, this PMR has been released.
On 9/24/13 the sponsor requested for deferral extension for PREA PMRs 4-1 and 4-2 and the Agency granted the request on 11/4/13.
Original milestone: January 1, 2009. Sponsor is awaiting further FDA guidance before proceeding.
Study complete, Report submitted 2/12/15 as S-009, UF not paid
The Sponsor submitted the study report, but they did not submit the NDA to support the pediatric dosage form because they do not plan on ever marketing the pediatric product.
2nd Deferral Extension granting letter issued on 10/27/2016. The final report submission due date revised from 12/31/16 to 06/30/2018
Study completed, results to be submitted
The study has not begun but does not meet the criterion for delayed. Deferral extension granted until 12/31/2018
The study is delayed. Currently negotiating the study protocol for the parent study with the FDA. An Acknowledge Revised Milestones letter was sent on June 2, 2015.
Supplement submitted to fulfill the PMR January 31, 2007;submission assigned (NDA#022176), submission did not satisfy the PMR as noted in the FDA NA letter dated March 8, 2008 and the PMR Not Fulfilled letter dated August 9, 2013.
The Sponsor met the goal of submitting the final protocol. The study has been initiated.
The final study report was submitted to FDA on 6/30/2015
The study/trial has not begun but does not meet the criterion for delayed.Original Final Report Due Date: 1/30/12 Deferral Extension Granted per FDA letter dated 7/10/13 revising the Final Report Submission date to 12/29/17.
The final report milestone was missed. Deferral Extension Requested 7/23/2013. Denied per FDA letter dated 9/9/2013.
Deferral Extension Requested 03/01/2016.  Denied per FDA letter dated 04/15/2016.
Dilaudid® and Dilaudid® HP (Hydromorphone Hydrochloride)
Deferral Extension Requested 03/23/2016.  Denied per FDA letter dated 05/02/2016.
The final Protocol was submitted on 05 Nov 2013. Subject enrollment has not initiated. The trial is planned to enroll up to 100 subjects.
CSR withdrawn; applicant granted deferral extension for CMC prep of pediatric formulation to satisfy Written Request
Per AP Letter Aug 11, 2004, the protocol due was date Feb 11, 2005, 6 month after application approval. Draft Adult PK protocol submitted August 10, 2006 Confirming status of protocol review with PK and clinical team Products is for treatment of contamination resulting from nuclear exposure events performed after exposure occurs
Original Final Report Due Date: 12/31/2010; Deferral Extension granted per FDA letter dated 03/25/2013. Protocol has been submitted
Per FDA letter dated 11/09/2016, this PMR has been fulfilled.
Per FDA letter dated 05/24/2016, this PMR has been released.
Revised milestone date for protocol is Sept 2012; study completion is June 2019 and study report is December 2019. The clofarabine arm of the study was closed based on results of pre-planned safety analysis. The Applicant will be discussing a new proposal with the Agency to address the PMR.
Per FDA letter dated 09/01/2016, this PMR has been released.
The final report was due in April, 2016.
Deferral Extension Requested 08/23/2016.  Denied per FDA letter dated 10/03/2016.
Lantheus report based on previous information from the previous owners the likelihood of receiving IRB approval to conduct this type of study would be difficult. Lantheus is currently conducting a thorough review of the published literature
Original 3-year follow-up due 4Q 2015 with final report due 2016. Three year follow-up is delayed. Applicant projects 3-year follow-up to be completed 3Q017 and Final report completion by 2Q2018. (Revised milestones acknowledged Dec 31,2014.)
Original Final Report Due Date: 10/31/2014; Deferral Extension granted per FDA letter dated 10/03/2016.
ActoPlus Met® (Pioglitazone and Metformin)
Duetact® (Glimepiride and Pioglitazone Hydrochloride)
Original Final Report Due Date: 12/31/2010. Per FDA letter dated 04/29/2013, Final Report due date extended to 04/25/2018. Second Deferral Extension Granted per FDA letter dated 01/25/2016.
Visicol® (Sodium Phosphate Monobasic Monohydrate & Sodium Phosphate Dibasic Anhydrous)
Additional rat toxicity study was required prior to initiating carcinogenicity study. FSR to be submitted during next reporting period (sponsor sent 12-JUL-16)
This PMC was to provide long-term safety and efficacy data in panic disorder patients. The sponsor has not initiated the study and submitted a waiver request dated 8/10/11. DPP denied the request, issued a PMC Not Fulfilled letter on 1/13/12, and requested the sponsor to submit a plan to fulfill the PMC.
Original milestone: October 1, 2007. Agency letter dated 2/24/2009 informed Sponsor that PMR was not adequately completed. Sponsor reports that they have reinitiated the study as of Jan 2014.
Per FDA letter dated 10/18/2016, this PMR has been fulfilled.
NDA WD 06/28/2012. Applicant does not plan to complete any of the studies that were initiated.
NDA Withdrawn withdrawal requested April 29, 2016 Guerbet indicates study files acquired during the acquisition of the product are deficient and data not usable.
No new information for this reporting period. Previous reporting period reported the following: The study/trial has not begun, and the Final Report Submission date of 6/30/12 has passed. Validus is diligently making every effort to start this study in 2016.
Original Study report due December 31, 2009. Applicant had difficulty with enrollment and modified the protocol to try to resolve the problem. Nov 4, 2013, Applicant requested release from PMR. May 28, 2013, FDA responded that Study for PMR 1994-3 should be completed before release can be considered. Final report for PMR 1994-3 is due September 2018.
Sponsor is awaiting for the Agency’s response for the clarification questions submitted
Deferred Study completion was due March 2016. Final report is due March 2017. Studies were closed out and a new study initiated.
Per FDA letter dated 03/17/2016, this PMR has been released.
Original milestone: March 1, 2008 Sponsor is awaiting further FDA guidance before proceeding.
The Final Report was submitted to FDA on 10/12/2016.
Synjardy® (Empagliflozin and Metformin Hydrochloride)
Complete recruitment was to be completed by 12/1/2009.
Enrollment is ongoing. As of 07 March 2016, 169 patients have been enrolled.
Pediatric studies – PK and safety. Milestones dates were revised to September 30, 2018.
Sponsor has withdrawn this NDA and does not intend to conduct this study
HalfLytely® and Bisacodyl Tablet (PEG-3350, Sodium Chloride, Sodium Bicarbonate, and Potassium Chloride; and Bisacodyl)
Valeant anticipates initiating study V01-BUPA-401 in Q4 2016 to meet NDA 22-108 Postmarketing Requirement (PMR 133-1) established under the Pediatric Research Equity Act (PREA) for conducting pediatric studies in the major depressive disorder indication.
VALEANT PHARMACEUTICALS NORTH AMERICA LLC
The final study report deadline has passed. The sponsor is currently negotiating the final study protocol with the FDA.
The Sponsor has not started the study yet. There is ongoing discussion with the Division regarding the study design.
Deferred trial completion was due March 2016. Final report is due March 2017. Studies were closed out and a new study initiated
The final report milestone was missed. Deferral Extension Requested 1/4/13. Denied per FDA letter dated 5/30/13.
Per FDA letter dated 12/14/2016, this PMR has been fulfilled.
Recruitment is slow, but the FDA requested enrollment continued to obtain more clinical data. Revised milestones acknowledged Nov 14, 2014 to complete study 2/1017 and submit the final study report July 2017
The pilot study that will guide the development of the final protocol for the main study is ongoing.
The study has not been initiated, but does not meet the criterion for delayed.
Per FDA letter dated 07/08/2016, this PMR has been fulfilled.
Sponsor requested a deferral extension. Deferral extension granted 7/9/13
Sponsor sumitted studies to support their argument that PMC 2a and 2b were unnecessary. However the FDA did not agree and a letter issued to sponsor on 12/28/09.  Novartis submitted new timelines on 4/13/10.
The Sponsor submitted a request for withdrawal of supplement S-005. FDA acknowledged withdrawal of this supplement on 1/11/13. FDA will release PMR 298 following publication of the FR notice.
The final study protocol deadline has passed, and the sponsor has not yet submitted a study protocol.
Per AP Letter Aug 11, 2004, the protocol due was date Feb 11, 2005, 6 month after application approval. Letter dated April 24, 2006 referenced a due date of Aug 11, 2004, 24 months after application approval date A 3 month extension was requested, submission dated July 31, 2006 Draft Peds PK study protocol submitted Nov. 10, 2006, PK review completed Oct. 11, 2007 and clinical review completed Sept. 4, 2007 both reviews found protocol acceptable Product is for treatment of contamination resulting from nuclear exposure events and studies are to start immediately after exposure and final reports due within 12 months of study initiation.
Per FDA letter dated 02/11/2016, this PMR has been released.
Protocols have been submitted [...]. Pediatric study is ongoing.
Original Final Report due date: 12/31/09. Deferral extension granted per FDA letter dated 4/12/13. The final report milestone date extended until 1/31/20.
Deferral extension granting letter issued on 07/02/2013. The trial has not initiated but does not meet the criterion for delayed. The final report due date revised from 01/31/2010 to 12/31/2019.
Per FDA letter dated 01/06/2017, this PMR has been fulfilled.
Lybrel® (Levonorgestrel and Ethinyl Estradiol)
Deferral granted December 22, 2015 due to enrollment difficulties. Final report submission due December 31, 2018.
As of March 2016, 109 prospective cases were enrolled into the current registry with INC Research. No longer able to execute VAMPPS protocol. Continue study  proposal to add a database to the current strategy is being evaluated.
Enrollment for the study is currently ongoing, 18 of 36 subjects enrolled
Technivie® (Ombitasvir, Paritaprevir, and Ritonavir)
Forty-five subjects have been enrolled in a pediatric pharmacokinetic study and 74 subjects have been enrolled in an open-label safety and tolerability extension study. Twenty-three subjects are enrolled in a long-term pediatric efficacy and safety study.
The Applicant needs to run tests on patient samples to complete the study. The Applicant has not submitted a final report that was due December 2004. The product is not currently being marketed. The associated IND has been inactivated.
Final report submission date is 11/29/19
Protocol is being revised for resubmission.
Original Final Report Due Date: 08/31/2015; Deferral Extension granted per FDA letter dated 7/9/2015. The study has enrolled 33 subjects. 32 subjects have completed the open label phase, there was 1 subject that had terminated early. The Sponsor is awaiting feedback from the FDA in regards to the amendments made to the protocol. The Amendment was made in order to support the completion of the study. Allergan plans to re-initiate the study in the fourth quarter of 2016, if the Agency feedback is received in early April.
Original Final Report Due Date: 03/31/2007; Deferral Extension granted per FDA letter dated 07/03/2013
AstraZeneca submitted a proposal on June 22, 2011. The FDA responded on October 1, 2014. No study has been initiated for the maintenance of healing of healing of erosive esophagitis portion of this PMR in patients aged 1 year to 11 years.
Final study report due on April 30, 2006, but has not been submitted to date. A PREA waiver request was submitted on October 11, 2004, but a determination has not been made.
Per FDA letter dated 01/17/2017, this PMR has been released.
Study start date of 1/2/2009 was missed.
PMR Release pending publication of WD in the FR
Per FDA letter dated 10/17/2016, this PMR has been released.
Opthalmologic Study -Enrollment in this study has been significantly below the original estimates. The Sponsor continues to proceed with the study and is looking at additional options to address slow enrollment and possible alternatives to address the protocol objectives.
Yasmin® (Drospirenone and Ethinyl Estradiol)
To assess the effect of the implant on the corneal endothelium, Bausch & Lomb will complete a casecontrolled study using a subset of approximately 100 patients from Clinical Studies BLP 415-001 and BLP 415-004 who have been implanted with Retisert for at least one year.” The study is delayed due to slow patient enrollment. Final Report Milestone of December 2006 missed.
Per FDA letter dated 08/24/2016, this PMR has been fulfilled.
The revised milestone proposal submitted on 06/05/15 and was acknowledged on 08/20/2015.
11/25/15, Semi-annual report submitted, 5708 enrolled.
The initial study submitted November 28, 2012 did not fulfill the PMC. (Not fulfilled letter sent March 24, 2015). The Applicant is developing a new protocol to address the PMC. The protocol is under discussion with the Agency.
The study/trial has not begun but does not meet the criterion for delayed.
Protocol submitted, final report due March 2017. It is a two part study, part 1 is ongoing, 2 is pending.
The study is terminated since the drug is no longer marketed.
Per FDA letter dated 01/09/2017, this PMR has been released.
The final study report deadline has passed. This study is dependent on completion of PMR 974-2.
The final study report milestone was missed. Deferral Extension Requested December 22, 2014. Denied per FDA letter dated February 6, 2015. Deferral Extension Request resubmitted March 26, 2015. Denied per FDA letter dated May 7, 2015.Proposed plan was inadequate and did not provide sufficient additional information that would allow FDA to alter previous decision to deny a deferral extension request. On May 20, 2015, FDA issued a Notification of Non-Compliance with PREA letter.
DuoDote® (Atropine and Pralidoxime Chloride) Auto-Injector
GE noted in their submission dated May 12, 2005 that the product has been discontinued and depleted from the US market. PMR/PMC Release Letter drafted and under review.
Revised Schedule: In a letter dated 15 March 2013, the FDA granted a deferral extension to the deadline for submission of the final clinical study reports for PMC #1229-1. Reasons for revisions: Slow enrollment, delay in start of Phase 3 due to findings during the FDA’s inspection of Cetero Labs, Houston, Texas
The Final Report Submission milestone was missed because of ongoing discussion with FDA regarding study design. Deferral Extension Requested May 14, 2013. Denied per FDA letter dated June 27, 2013. A draft protocol was submitted for FDA review on October 28, 2015.
The study has not yet begun but does not meet the criteria for delayed.
The Protocol Submission Date milestone for this PREA PMR has been missed.
Per AP Letter Aug 11, 2004, the protocol due was date Feb 11, 2005, 6 month after application approval. A 3 month extension was requested, submission dated July 31, 2006 Draft longitudinal study protocol submitted Nov. 10, 2006, PK review completed Oct. 11, 2007 and clinical review completed Sept. 4, 2007 both reviews found protocols acceptable
Per FDA letter dated 01/24/2017, this PMR has been released.
NDA request to WD received Feb 6, 2014, FDA WD Acknowledgement letter signed Feb 12, 2014, PMR Release pending publication of WD in the FR
The final protocol and study completion milestones were missed.
The study has not begun but does not meet the criterion for delayed.
Fulfilled per the FDA letter dated 10/6/16
The final protocol milestone was 5/31/2013. Sponsor has to reach legal agreement to join the joint sponsor protocol.
Protocol was submitted on September 30, 2011. It was discussed with the FDA on December 15, 2014. On May 12, 2015, Indivior submitted a revised protocol for FDA’s review and received a response from FDA on July 28, 2015. Indivior is currently in the process of finalizing a revised protocol based on FDA’s recommendations and will resubmit the revised version for FDA’s review prior to implementing it.
Study status: FMCNA requested that the Agency release the study commitment on February 22, 2013. The study is terminated.
Draft Protocol and Final Protocol submitted by PMR milestone due dates
Lymphoseek™ (Technetium Tc 99m Tilmanocept )
The final report due date has passed with no final report received.
Liposyn® II (Safflower Oil and Soybean Oil [Fat Emulsions])
Embeda™ (Morphine Sulfate and Naltrexone Hydrochloride)
Targiniq™ ER (Oxycodone Hydrochloride and Naloxone Hydrochloride)
MALLINCKRODT INC THE PHARMACEUTICALS BUSINESS OF COVIDIEN
Photrexa® Viscous (Riboflavin 5'-Phosphate), Photrexa® (Riboflavin 5'-Phosphate), and KXL™ System
Viekira® XR (Dasabuvir, Ombitasvir, Paritaprevir, and Ritonavir)
A protocol is being drafted and will be submitted for Agency review 1Q2017 following completion of the definitive juvenile toxicology study.
The final report milestone was missed because of additional time needed to develop an appropriate assay. FDA determined that the applicant demonstrated good cause for the delay.
The Division agreed that the sponsor could terminate the clinical study EPOI014 due to problems with evaluation of the lower doses. However, the Division did not agree to release PMC #3 until the results of the other commitments are submitted and reviewed. The final report has not been submitted. Provide safety and efficacy data from a 2-year (minimum) clinical study of at least two additional doses of Macugen below 0.3 mg.
The trial has completed enrollment. The final report is expected in April 2017.
Per FDA letter dated 09/02/2016, this PMR has been released.
The final report milestone was missed, due to poor subject enrollment and the FDA determined that the applicant demonstrated “good cause” for the delay. The final study report was received on 10/17/2016 which was on time and according to the revised milestone schedule.
The final report milestone was missed, because PMR 1673-2 is contingent upon finding a safety signal in PMR 1673-1 and the FDA determined that the applicant demonstrated “good cause” for the delay.
Per FDA letter dated 06/20/2016, this PMR has been fulfilled.
The protocol finalization milestone was missed because of ongoing discussion with FDA regarding study design.
This study titled “Provide clinical information from a (minimum) 1-year study to support that there are no adverse effects on the corneal endothelium following intravitreal administration of Macugen.” As of December 2015, the study has over 100 subjects enrolled. The last patient first visit is scheduled for 31 December 2015. Due to slow enrollment the final report submission date of July 2008 was missed.
The final protocol due date has passed with no final protocol received.
The Study Completion milestone was missed because of difficulties in subject recruitment and enrollment; FDA determined that the applicant demonstrated sufficient justification for the delay. Original Final Report Due Date: 09/30/2011; Deferral Extension granted per FDA letter dated 01/25/2016.
Janumet® (Metformin Hydrochloride and Sitagliptin Phosphate}
PMC not fulfilled letter signed on 8/25/2010.
As of the cutoff date, 3/20/16, 3 of the planned 32 subjects have been enrolled
The study has been initiated.85 patients out of the planned 180 patients have been enrolled into the trial.
Deferral Extension Requested 07/28/2016.  Denied per FDA letter dated 09/16/2016.
A total of 34 patients were enrolled in the study, no patients are ongoing in the study, 4 patients withdrew from the study, and 30 patients completed the study.
2354 patients enrolled of the total 2300 planned for enrollment
The final report submission milestone was missed because of delays involving organization of a large multicenter international trial and additional time required to enroll a larger number of trial subjects than originally planned. Original Final Report Due Date January 1, 2016; Deferral Extension granted per FDA letter dated October 20, 2015.
The final report milestone was missed because of difficulties in recruitment.
Per FDA letter dated 08/16/2016, this PMR has been fulfilled.
Difficulties in recruiting patients despite initiatives to increase enrollment.
Per FDA letter dated 10/13/2016, this PMR has been released.
Final protocol submission date of May, 2014 was not met. The Sponsor submitted the protocol on 12/21/2015, according to the new timeline they proposed in 2014.
35 subjects have been treated subjects: 7 (6 months to < 2 years), 28 (2 to < 6 years) since Jan 2015. Trial completion is due December 2019.
3 subjects have been treated since Nov 2015. Trial Completion is due 12/2019
Suprep® Bowel Prep Kit (Sodium Sulfate, Potassium Sulfate, and Magnesium Sulfate)
The Sponsor did not meet the original timelines, new timelines acknowledged on June 23, 2015
The study was initiated 2nd quarter of 2011. Original Final Report Due Date: 06/30/2015; Deferral Extension granted per FDA letter dated 05/30/2015. The deferral extension was granted because of difficulties experienced in recruiting study participants. Revised Final Report Submission date: 06/30/2018
The final study report milestone was missed. The sponsor has submitted withdraw of this NDA and will not be conducting this study.
As of September 15, 2015, 38 of the 165 patients have been enrolled into the trial.
The final protocol milestone was missed due to re-evaluation of pediatric dosing and harmonization of milestones with concurrent PMR study.
The final report milestone was missed. Original Final Report Due Date: 5/31/14. Per FDA letter dated 7/1/15, final report due date extended to 7/31/16.
The Final Report Submission milestone was missed because trial initiation was delayed due to protocol discussion with FDA and additional analyses were required that were expected to lengthen the report preparation time between trial completion and final report submission. FDA determined that the applicant demonstrated “good cause” for the delay.
The trial has not been completed because additional patient recruitment is required to complete the trial. FDA issued an acknowledge revised milestones and sufficient justification for anticipated delay of postmarketing requirement milestones letter on 6/20/16.
The trial completion milestone was missed because the required juvenile animal study data were under review by the Agency until November 6, 2015. FDA determined that the applicant demonstrated sufficient justification for the delay. Original Final Report due date: May 2016; Deferral Extension granted per FDA letter dated 04/07/2016.
The Final Protocol Submission milestone was missed, because of ongoing discussion with FDA regarding the study design and FDA determined that the applicant demonstrated sufficient justification for the delay. Original Final Report due date: September 2018; Deferral Extension granted per FDA letter dated 09/30/2016.
Forty-five subjects have been enrolled in a pediatric pharmacokinetic study and 74 subjects have been enrolled in an open-label safety and tolerability extension study. Twenty-three subjects are enrolled in a long-term pediatric efficacy and safety study.
Prestalia® (Perindopril Arginine and Amlodipine Besylate)
The study was initiated on September 30, 2015. Three sites of seven have been initiated and enrolled patients. The trial Completion is due February 28, 2017
Final Protocol Submission is due March 31, 2018
The trial is ongoing. Trial Completion is not due until March 2016
Peds study final study report due in 2018
The study is recruiting patients. Original Final Report Due Date: 8/31/16; Deferral Extension granted per FDA letter dated 5/27/16.
Prepopik™(Sodium Picosulfate, Magnesium Oxide, and Citric Acid)
168 subjects have been treated: 113 (12 to < 18 years), 55 (6 to < 12 years) since Nov 2014. Trial Completion is due 12/2022.
Invokamet™ (Canagliflozin and Metformin Hydrochloride)
The trial has not begun but does not meet the criterion for delayed
Original Final Report Due Date: 12/31/2012. Per FDA letter dated 12/02/2013, final report due date extended to 08/31/2015. Second Deferral Extension Granted per FDA letter dated 12/29/2016.
The Final Protocol Submission milestone was missed, because of ongoing discussion with FDA regarding the study design and FDA determined that the applicant demonstrated good cause for the delay.
ONYX THERAPEUTICS INC A WHOLLY OWNED SUB OF AMGEN INC
The first interim report submission due on March 31, 2014, was missed. The applicant proposed revised milestones to harmonize submission of these interim reports with PSURs reported annually in June. FDA determined that the applicant demonstrated good cause for the delay.
Kazano® (Alogliptin and Metformin Hydrochloride)
The drug product application Clonidine ER Oral Suspension has been discontinued. Accordingly, at the present time the above stated commitments remain unmet. If the drug product application, Clonidine ER Oral Suspension, is reinstated and becomes again a marketed product, Tris commits to fulfill above commitment.
9 patients out of the planned 260 patients have been enrolled into the trial.
Final Study Report submitted March 11, 2016
64 subjects have been treated: 24 (12 to < 18 years), 40 (6 to < 12 years) since Feb 2013. Trial completion is due 12/2016.
The final report milestone was missed because of slow enrollment. The applicant has not requested a deferral extension.
Per FDA letter dated 07/12/2016, this PMR has been released.
The Sponsor is still having difficulty with study enrollment. The original final report was due 6/2016. The 2013 revised final report was due 12/2016
Sponsor submitted new study protocol 17- MAR-15 and on 26-MAY-15, FDA requested revisions. Clinical trial commitment status is pending.
Truvada® (Emtricitabine and Tenofovir Disoproxil Fumarate)
The trial will be extended for two additional years to allow for potentially more data collection.
Milestone revised to have additional time for subject follow-up, data collection and reporting.
Milestone revised to have additional time to enroll adequate number of subjects
Deferral Extension Requested 06/08/2016.  Denied per FDA letter dated 07/25/2016.
Per FDA letter dated 12/22/2016, this PMR has been fulfilled.
Final Study Report submitted June 3, 2016, prior to the milestone date. Guerbet's required PREA PMR pediatric assessment and labeling supplement for PMR 2021-2, which was deferred until June 30, 2016, hasn’t been submitted. Guerbet’s response to the Notification of Non Compliance with PREA letter confirmed the proposed labeling supplement will be submitted no later than October 31, 2016.
The Final Report was submitted to FDA on 9/16/16
7 patients out of the planned 210 patients have been enrolled.
3835 patients out of the planned 4000 have been enrolled. Final protocol milestone was missed because the draft protocol required significant modifications based upon the Agency’s recommendations and the FDA determined that the applicant demonstrated good cause for the delay.
Original Final Report Due Date: 09/30/2016; Deferral Extension granted per FDA letter dated 07/20/2016
Zutripro® (Hydrocodone Bitartrate, Chlorpheniramine Maleate, and Pseudoephedrine Hydrochloride )
Original Final Report Due Date: 09/30/2016; Deferral Extension granted per FDA letter dated 07/20/2016.
Rezira® (Hydrocodone Bitartrate and Pseudoephedrine Hydrochloride)
Original Final Report Due Date: 05/31/2018; Deferral Extension granted per FDA letter dated 11/25/2014.
GLAXOSMITHKLINE INTELLECTUAL PROPERTY MANAGEMENT LTD ENGLAND
The study was initiated on September 4, 2012 and was terminated on November 29. 2013 due to the imposition of a full clinical hold. At the time of the clinical hold four subjects had been enrolled.
Study completion date of July 31, 2015 is delayed. Per sponsor, enrollment of investigators and patients was challenging before safety issues were identified and has become more challenging since implementation of additional monitoring. As of June 10, 2015, six subjects have been enrolled.
Original Final Report Due Date: 11/30/2014; Deferral Extension granted per FDA letter dated 9/26/2014. Final Report due date extended to 04/30/2017. Original Study Start Date: 05/30/2012 extended to: 10/31/2014. Original Study Completion: 05/30/2014 extended to: 10/31/2016
The final protocol submission milestone was missed because of difficulty in obtaining a suitable formulation.
The trial has not begun but does not meet the criterion for delayed.
Final protocol revisions submitted May 13, 2015. The study is anticipated to be initiated in fourth quarter of 2015
Final study report submitted on 7/28/16.
Symbicort® pMDI (Budesonide and Formoterol Fumarate)
"The draft protocol was submitted[...] on December 18, 2013 with a cross reference letter to the NDA and to comply with the postmarketing requirement protocol submission. FDA responded indicating that the proposed study is on Full Clinical Hold pending resolution of deficiencies in a letter dated 01/31/2014."
The first interim report submission milestone was missed because the applicant wishes to harmonize reporting dates to FDA and EMA. FDA determined that the applicant demonstrated “good cause” for the delay.
Per FDA letter dated 10/28/2016, this PMR has been fulfilled.
TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC
The final protocol submission milestone was missed because we were waiting for data from the PK study (PMR 2000-1) and had not yet agreed on study design; pediatric studies are now on hold while sponsor investigates safety issues.
Agency issued communication on 14-OCT-14 that the FSR related to PMR did not fulfill PMR requirements. Pfizer proposed remediation plans and revised milestones which were acknowledged by FDA 8-DEC-14. Target accrual would be 30 pts who complete all 10 ophthalmology tests at baseline, Cycle1 Day 15 and Cycle 3 Day 1.
On 18-FEB-14, Pfizer submitted a revised timeline and study design change to the FDA to use “itraconazole” instead of ketoconazole due to revised safety guidelines. New milestones acknowledged 10-APR-14
Status update on study was provided on 26-MAR-15 that included current issues with trial enrollment, a proposal and updated timeline. Revised timelines acknowledged 20-APR-15
Final report submission was due 12/31/14
The final study report was submitted on 12/15/15. The prior approval supplement was submitted on 6/7/16
Vimovo® (Esomeprazole Magnesium and Naproxen)
The final protocol milestone was missed, because the FDA was engaged in discussion with the applicant regarding the study design at the time the final protocol submission milestone was due and FDA determined that the applicant  demonstrated good cause for the delay.The trial is now ongoing.
The final protocol submission milestone was missed due to issues with the study and comparator drug. The sponsor provided sufficient justification for missing the final protocol milestone.
Vituz® (Hydrocodone Bitartrate and Chlorpheniramine Maleate)
As of April 1, 2016, 12 investigators with 15 sites in total have enrolled 65 subjects of whom, 47 have completed the study and 7 were discontinued/early termination. Currently, there are 8 investigators with 10 active sites. One thousand eighty-four patients have been screened since recruitment was initiated in February 2014. The total number of planned subjects is 160 pregnant adolescents to achieve 128 evaluable participants based on a drop-out rate of 20%.
Diclegis® (Doxylamine Succinate and Pyridoxine Hydrochloride)
On March 26, 2014, the FDA issued a letter to the Sponsor requesting the submission of an additional study in order to fulfill the PMR.
Nuedexta® (Dextromethorphan Hydrobromide and Quinidine Sulfate)
The Sponsor submitted the final report on 12/18/2015
Ultracet® (Acetaminophen and Tramadol Hydrochloride)
Trial completion milestone missed, FDA determined there was good cause for the delay
Sponsor discontinued enrollment in the PMR study February 6, 2015. A meeting with the division was held January 6, 2016 to discuss a possible alternative study. A proposed protocol was submitted and not found to be acceptable. Sponsor is in the process of evaluating additional options for a replacement clinical study.
The sixth interim report was submitted October 26, 2016. The sixth interim report was due 12/2015. The reports are delayed due to late launch of Marqibo. (Milestones were revised 10/24/2014)
Per FDA letter dated 07/27/2016, this PMR has been released.
The final protocol milestone was missed due to the time required for the Agency and the applicant to come to agreement on the protocols for these trials. The FDA determined that the applicant demonstrated good cause for the delay. Acknowledge Revised PMR Milestones letter issued per FDA letter dated 1/21/16.
The protocol finalization milestone was missed because of discussion with FDA regarding study design.
The final report submission milestone was missed because of subject recruitment difficulties.
Dulera® (Formoterol Fumarate and Mometasone Furoate)
The final study report submitted with efficacy supplement on 07/28/16 and under FDA review.
Stribild® (Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir Disoproxil Fumarate)
A request for release from this study was denied per 04/05/2016 FDA letter, but will reevaluate as another pediatric development program progresses.
The final study report milestone was missed. The sponsor requested withdrawal of NDA 203595 on 7/9/15 and does not intend to perform the required postmarketing studies.
Suclear™ (Sodium Sulfate, Potassium Sulfate, and Magnesium Sulfate; and PEG-3350, Sodium Chloride, Sodium Bicarbonate, and Potassium Chloride)
The final protocol submission milestone was missed. The sponsor requested withdrawal of NDA 203595 on 7/9/15 and does not intend to perform the required postmarketing studies.
The study has not begun but does not meet the criterion for delayed. The sponsor requested withdrawal of NDA 203595 on 7/9/15 and does not intend to perform the required postmarketing studies.
The final protocol submission milestone was missed. The sponsor requested withdrawal of NDA 203595 on 7/9/15 and does not intend to perform the required postmarketing studies.
Deferred pediatric studies under PREA for treatment of partial onset seizures in patients ages 1 month to 16 years. Milestone dates were revised to September 30, 2018.
The original final study report due date of 12/31/2014 was extended to 3/31/2016 due to challenges in enrollment.
Per FDA letter dated 12/16/2016, this PMR has been fulfilled.
The study completion milestone was missed due to safety and pharmacokinetic issues. Final report deferral extension granted per FDA letter dated 5/2/16.
The final protocol has not been submitted and the trial completion and final report submission milestone dates have been missed.
GLAXO GROUP LTD ENGLAND DBA GLAXOSMITHKLINE
Advair® Diskus® (Fluticasone Propionate and Salmeterol)
16/20 subjects completed as of 10/6/2015. FDA Deferral Extension Granted letter signed 12/30/2014 changing Final Study report due date to: June 2017.
Sponsor requested withdrawal of the NDA. FDA acknowledged withdrawal request in letter dated 4/17/15.
Final report was due November 2015. On October 14, 2015, FDA granted a pediatric deferral extension. The new final report submission date is November 2019. Firm reports 173 of 200 subjects enrolled as of October 1, 2016.
Original Final Report Due Date: 12/31/2014; Deferral Extension granted per FDA letter dated 06/24/2013.
Deferral extension granted 6/24/2013. The study is ongoing as per revised milestone
The Final Report was submitted to FDA on August 31, 2016.
The protocol finalization milestone was missed because the final study design is dependent on completion of PMR 1766-1; the final study report for PMR 1766-1 is currently under FDA review. Original Final Report Due Date: September 30, 2017; Deferral Extension granted per FDA letter dated December 18, 2013.
Original Final Report Due Date: 02/28/2014; Deferral Extension granted per FDA letter dated 01/30/2014.
Original Final Report Due Date: 08/31/2015; Deferral Extension granted per FDA letter dated 08/12/2015.
Original Final Report Due Date: 02/28/2017; Deferral Extension granted per FDA letter dated 12/29/2016.
This study is not scheduled to start until review of the study data for commitment 1834-3 is complete and an appropriate dose for this age group is identified
FDA issued a not fulfilled letter on 7/11/14. The final protocol milestone was missed. FDA determined that the applicant demonstrated “good cause” for the delay. A new final study report was submitted on 3/21/16.
The final report submission was due 3/31/2014. Sponsor unable to complete this PMR until PMR 1895-2 is complete. FDA determined that the applicant demonstrated “good cause” for the delay.
Original Final Report Due Date: 10/31/2016.  Per FDA letter dated 01/22/2015, final report due date extended to 06/30/2017. Second Deferral Extension Granted per FDA letter dated 09/29/2015. Final report submission now due December 2017
Taclonex® (Calcipotriene and Betamethasone Dipropionate)
Schedule revised due to enrollment rate.
Original Final Report Due Date: 01/31/2016; Deferral Extension granted per FDA letter dated 08/28/2015.
ORGANON USA INC A SUBSIDIARY OF MERCK AND CO INC
BIPI submitted the final report for study 1160.105 to NDA 022512 on August 1, 2016. BIPI considers PMR 2139-1 to be fulfilled.
The final protocol has not been submitted and the trial completion milestone date has been missed.
The Final Report Submission milestone was missed because additional analyses will be required based on discussion with FDA, and FDA determined that the applicant demonstrated “good cause” for the delay.
The final protocol milestone was missed, because the FDA was engaged in discussion with the applicant regarding the study design at the time the final protocol submission milestone was due and FDA determined that the applicant  demonstrated good cause for the delay.
Final Protocol submitted after milestone date
Per FDA letter dated 07/26/2016, this PMR has been fulfilled.
On November 18, 2013, Teva submitted extension request in Sequence 0074. On November 27, 2013, FDA granted Teva’s extension request for PMR 1891-2 with a final report submission date of April 13, 2018.
On August 26, 2015 (Sequence 0103), Teva requested a change in timetables for PMR 1891-4 study completion and final report submission due to the extremely slow patient enrollment into the requirement postmarketing observational study that was discussed at the May 21, 2015 Type B meeting. On November 30, 2015, FDA issued acknowledge revised postmarketing requirement milestones letter granting the extension for study completion of October 1, 2019 and final report submission of March 31, 2020.
The final report submission milestone was missed and FDA determined that the applicant failed to demonstrate “good cause” for the delay.
Original Trial Completion due date was August 31, 2014. Previously revised milestones to trial completion: Aug 31, 2016 and Final Report due Aug 31, 2017. Nov 15, 2016, applicant requested new revised milestones. Based on original milestone dates, the study is delayed.
Final Protocol was due June 2013. Sponsor will submit in March 2014
Final Protocol not yet submitted. Sponsor will submit in March 2014
Per FDA letter dated 12/14/2016, this PMR has been fulfilled
The final report milestone was not missed, however, the sponsor did not achieve study endpoints for PK and subsequently received a complete response
The final report milestone was missed, because of ongoing study design discussions with the Division
Study A0221047 has been initiated with pediatric patients being screened and enrolled. Final Study report due on 6/30/17
The final protocol submission milestone and the final study report milestones were missed.
The original milestone for the final protocol submission (August 2012) was missed. Final reports for two previously conducted trials were submitted by the applicant on August 24, 2012. FDA issued a PMR Not Fulfilled letter on May 3, 2013. The applicant requested to submit revised milestones for a new study. FDA determined that the applicant had good cause for failure to comply with the missed milestone dates and issued an Acknowledge Revised Milestones letter on December 2, 2014. The final protocol was submitted on April 28, 2015, in accordance with the revised schedule. The trial has not yet initiated. The revised milestone dates are January 2016 for trial completion and April 2016 for submission of the final report.
Approximately 1013 subjects have been enrolled out of a planned 1300 subjects. The Study completion milestone and the final study report milestone was missed, because of additional time needed to enroll a larger number of subjects than originally planned. FDA determined that the applicant demonstrated “good cause” for the delay.
NDA product withdrawn from the market during investigation of adverse events. Studies on hold.
NDA product withdrawn from the market during investigation of adverse events. Studies on hold
NDA product withdrawn from the market during investigation of adverse events. Studies on hold. Good Cause Letter sent May 3, 2013.
NDA product withdrawn from the market during investigation of adverse events. Studies on hold. Good Cause Letter sent May 3, 2013
Study enrollment was initiated in April 2011. On March 25, 2015 Pfizer submitted a request to extend the due date for the final study report to December 6, 2018, due to difficulties with enrollment of the younger adolescent cohort. A revised PWR was issued on May 11, 2015
Sponsor has not provided any update. A Deferral was granted on 3/2/2015, with a final report submission in Dec. 2016.
Original Final Report Due Date: 01/31/2015; Deferral Extension granted per FDA letter dated 05/17/2016.
UNITED STATES ARMY OFFICE SURGEON GENERAL
The final protocol due date of 06/20/2013 has been already passed and the Sponsor submitted only the partial protocol.
Per FDA letter dated 06/28/2016, this PMR has been fulfilled.
Advil® Congestion Relief (Ibuprofen and Phenylephrine Hydrochloride)
Per FDA letter dated 07/11/2016, this PMR has been released.
Advil® Allergy and Congestion Relief (Ibuprofen, Phenylephrine Hydrochloride, and Chlorpheniraline Maleate)
Per FDA letter dated 05/16/2016, this PMR has been fulfilled.
The study has not begun but does not meet the criterion for delayed. Deferral extension granted until 6/30/2019.
Per FDA letter dated 11/10/2016, this PMR has been fulfilled.
Per Agency instruction, this study was terminated on August 5, 2015, due to increased mortality.
The PREA Deferral Extension, requested on May 20, 2016, was granted on June 30, 2016 and the final report due date is revised from December 2016 to September 2017.
Thirty evaluable patients are enrolled in the study and the study is ongoing. The Phase 1 trial completion date (August 31, 2011) and the Phase 3 Protocol submission date (September 30, 2011) have been missed.
Enrollment is continuing in all age groups.
To date, 100 patients have been screened, 79 enrolled, and 72 have completed the study
The final report milestone was missed. Deferral Extension Requested October 15, 2014. Denied per FDA letter dated March 3, 2015. Sponsor has not made good faith attempts to conduct the required studies. PREA noncompliance letter was issued April 24, 2015.
174 patients have been screened; 73 have been randomized.
The PMR was fulfilled per FDA letter dated 7/12/2016
Original Final Report Due Date: 07/25/2018; Deferral Extension granted per FDA letter dated 01/28/2016.
Original Final Report Due Date:07/25/2020; Deferral Extension granted per FDA letter dated 01/28/2016
The final report was submitted on 10/31/2014. FDA determined not to fulfill the PMR because the validation parameters and the analytical method were incomplete per the letter dated 12/10/2015.
Per FDA letter dated 06/07/2016, this PMR has been released.
Deferred pediatric study under PREA. Final protocol submitted and accepted. No subjects have been enrolled in the study. Final report due December 15, 2019
The final protocol milestone was missed due to challenges selecting study endpoints and duration. The sponsor is working with FDA on the protocol.
Per FDA letter dated 02/03/2016, this PMR has been fulfilled.
Final report submitted on 05/30/2008. Labeling supplement was submitted 09/29/2008.
Botox® and Botox® Cosmetic (OnabotulinumtoxinA)
A total of 40 of the planned 240 patients have been entered into this study. The study is ongoing.
A total of 30 of the planned 100 patients have been entered into this study. The study is ongoing
The trial completion milestone was June 2016. Recruitment efforts were slower than expected causing a delay in trial completion. Teva requested a revised timeline on March 31, 2016 which was agreed to May 11, 2016
Astellas is assessing a current body of data which supported the approval in Europe and other countries of a tacrolimus immediate- release granule formulation (Modigraf®) which may be appropriate for dosing pediatric patients < 5 years. Astellas is currently requesting pre-NDA meetings.
A total of 81 pediatric patients have been exposed to tacrolimus extended release capsules as of the close of the reporting period. Subjects continue to be followed for 1 year. The last subject is expected to complete the 1-year follow-up in October 2016.
The study completion date has passed and the study has not yet been completed.
2 patients have been enrolled into the trial
The study has not been initiated, but does not meet the criterion for delayed
Original Final Report Due Date: 12/30/2016; Deferral Extension granted per FDA letter dated 12/06/2016.
PMCs in 6/28/13AP ltr. Status has not been reported yet.
Zubsolv® (Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate )
Per FDA letter dated 02/23/2016, this PMR has been fulfilled.
The final protocol milestone was missed, because the FDA was engaged in discussion with the applicant regarding the study design at the time the final protocol submission milestone was due and FDA determined that the applicant demonstrated good cause for the delay.
FDA has determined that you had good cause for your failure to comply with the Trial Completion milestone of the original timetable of 01/31/2017.
Reported enrollment of 62 subjects as of this reporting period.
Reported 7 subjects as of this reporting period.
Enrollment completed on 8/22/14 (944 patients), 1-year follow-up ongoing. 8/22/14 Final Study Report due date revised to be submitted 9/2017
New pediatric studies to replace 572-1. The sponsor reports that 606 subjects have been enrolled and enrollment is complete.
New pediatric studies to replace 572-1; the study has not been initiated, but does not meet the criterion for delayed
Original Final Report Due Date: 03/31/2016; Deferral Extension granted per FDA letter dated 01/06/2017.
Xartemis™ XR (Acetaminophen and Oxycodone Hydrochloride)
Original Final Report Due Date: 06/01/2018; Deferral Extension granted per FDA letter dated 01/06/2017
Original Final Report Due Date: 07/01/2020; Deferral Extension granted per FDA letter dated 01/06/2017.
Efforts toward developing an age appropriate formulation are proceeding according to the original schedule.
Good Cause letter sent to sponsor and new milestones ack on 18-NOV-15 due to accrual limitations
Study 1 (pJIA), enrollment completed with 52 patients. Study 2 (sJIA), current enrollment 41 patients
Deferral Extension Requested 03/11/2016.  Denied per FDA letter dated 04/26/2016.
The final protocol milestone was missed, because the sponsor has not provided a plan or evidence of formulation development. Deferral Extension Requested November 11, 2015.
The study has not begun but does not meet the criteria for delayed. Deferral Extension Requested November 11, 2015.
Per FDA letter dated 06/15/2016, this PMR has been released.
The study/trial has not begun but does not meet the criterion for delayed
Enrollment complete in the normal and mild hepatic dysfunction groups. Enrollment of moderate and sever groups expected completion June 2017 with trial completion December 2017
PMR fulfilled per FDA letter dated 7/12/16.
The study completion and final study report milestones were missed. 309 patients have been enrolled.
Final report submitted to FDA on 5/27/16
The Sponsor is currently negotiating a revised study protocol with the FDA.
MEDICIS PHARMACEUTICALS A DIV OF VALEANT PHARMACEUTICALS NORTH AMERICA LLC
Original final report due date: 10/31/13. Deferral extension granted until 6/30/19 per FDA letter dated 3/18/14.
Sponsor notified Agency of likely delay with FSR due to inadequate subjects accrued in Jan 16– more subjects needed in severe hepatic group. Failure to Show Good Cause letter sent to sponsor 3-OCT-16.
Final report submitted on March 31, 2016.
Study completion date is December, 2016.
Final protocol submission date is September, 2017.
Original Final Report Due Date: 03/31/2014; Deferral Extension granted per FDA letter dated 03/24/2014
Original Final Report Due Date: 11/30/2013; Deferral Extension granted per FDA letter dated 04/04/2016.
The final report due date has passed with no final report received
Liposyn® III (Soybean Oil [Fat Emulsion])
The original Final Report submission milestone (7/15/2014) was missed. (As of 6/30/2016: 13 patients exposed)
The final protocol submission milestone was missed, because protocol negotiations were ongoing.
Per FDA letter dated 03/21/2016, this PMR has been fulfilled.
Deferral Extension Requested 02/08/2016.  Denied per FDA letter dated 03/18/2016.
The final protocol submission milestone was missed because an additional exploratory study was needed prior to finalizing the protocol for the definitive study. FDA determined that the applicant demonstrated “good cause” for the delay.
The final protocol submission milestone was missed because the applicant proposed to delay protocol finalization until more of the primary cardiovascular events have been reached in the cardiovascular outcomes trial to allow for a more robust assessment of the bladder cancer event rate. FDA determined that the applicant demonstrated “good cause” for the delay.
Per FDA letter dated 03/22/2016, this PMR has been fulfilled.
The final protocol milestone was missed. Draft protocols under FDA review.
Due to delay in enrollment, agreement was obtained to submit the final report by April 2015. Final study report submitted on 29 Apr 2015.
This study has not been initiated, but does not meet the criterion for delayed.
Delayed due to study completion date and final report submission date.
Deferral Extension Requested 05/25/2016.  Denied per FDA letter dated 06/29/2016.
Final protocol submission date is September, 2016
Final protocol submission date is 12/2015
The Sponsor had difficulties with patient enrollment.The patient accrual milestone has been missed.The study is delayed. Original milestones: patient accrual by July 2016; trial completion June 30, 2019; Final report and database submission December 2019. (Nov 10, 2015 Annual Report Revised Patient Accrual Completed: by December 2017; Clinical Trial Completed: by December 2020; Final Report and Database Submission: by June 2021). November 15, 2016 Annual Report requests revised milestones: Patient Accrual Completed by December 2018; Clinical Trial completed by December 2021; final report and database submission: June 2022.
Enrollment completed on 1/2014 (846 patients). 12/29/15 Final Study Report due date revised to be submitted on 12/2024.
No longer enrolling for the study- See section D for further explanation.
Merz Pharmaceuticals GmbH c/o Merz Pharmaceuticals LLC
The final report milestone was missed, because the FDA was engaged in discussion with the applicant regarding the study design at the time the final report submission milestone was due and FDA determined that the applicant demonstrated good cause for the delay.
Recruitment ongoing, 738 subjects enrolled. Revised milestone letter issued 10/21/14. Final report submission October 2016.
First subject dosed on Nov 4, 2014; 8 subjects enrolled as of Jan 7, 2016..
Final Protocol Submission is due 12/14/2016.
Per FDA letter dated 11/14/2016, this PMR has been released..
The final protocol milestone was missed because data analysis was not complete.
2,402 patients have been enrolled in the study. Enrollment was complete Nov 8, 2011. The final report was due September 29, 2012. Extended to January 2021.
Mircera® (Methoxy Polyethylene Glycol-Epoetin Beta)
Deferral Extension Granted per FDA letter dated 07/16/2013.
The final report submission milestone of 3/30/2015 was missed. The sponsor is working with the FDA to discuss options to modify the protocol. Two patients were enrolled in the study as of the end of the reporting period.
FDA issued a not fulfilled letter 6/20/2014. The sponsor is working with the FDA to discuss options to fulfill the PMC.
The study completion milestone was missed. The sponsor has been working on a revised protocol with the FDA.
Final report is deferred to August 2018.
Missed final protocol submission date 12/2008. Delay in study start. As of 12/22/2015, enrollment 295, target 500. First interim report submitted on time in 6/2014.
Final study report had been deferred to June 2017; however, long term extension discontinued in March 2014. Final study report planned for December 2014.
As of December 2013, 40 patients have been enrolled in the study.
Final Study report is deferred to August 2017.
January 5, 2009, FDA replaced PMC-1 with two new PMCs: PMC 38-1 and PMC 38-2. (PMC 38-1 was fulfilled May 30, 3013).
Contrave® (Naltrexone Hydrochloride and Bupropion Hydrochloride)
Study 191622-121 is ongoing with 39 subjects currently enrolled and 12 subjects having completed the study. Allergan plans to enroll 100 subjects.
The study is proceeding according to the original schedule.
The protocols for the clinical safety studies have not yet been finalized by the  Sponsor.
The study completion and final report due dates have not been met.
Enrollment completion/observation completion dates, 6/2009 & 6/2014 missed. Enrollment target 5000, as of 6/30/2015, 1370 enrolled. FSR due 12/31/16.
The trial was terminated on the basis of futility. The final report is expected by March 31, 2016.
Enrollment for the study is currently ongoing.
The final protocol milestone was missed because the protocol has not been agreed upon.
Original Final Report Due Date: 01/15/2016; Deferral Extension granted per FDA letter dated 11/23/2016.
Deferral Extension granted in FDA letter dated August 15, 2014. Current enrollment, 7 patients.
Zerbaxa® (Ceftolozane Sulfate and Tazobactam Sodium)
The final report milestone was missed because one of the studies contributing to the results is ongoing because of difficulty with enrollment. FDA determined that the applicant demonstrated good cause for the delay.
Study 191622-120 is ongoing with 61 subjects currently enrolled and 37 subjects having completed the study. Allergan plans to enroll 132 subjects.
Descovy® (Emtricitabine and Tenofovir Alafenamide)
Natazia® (Estradiol Valerate; and Estradiol Valerate and Dienogest)
Revised draft protocol submitted on 2/26/16, which is under review
Original Final Report Due Date: 06/30/2017; Deferral Extension granted per FDA letter dated 01/10/2017.
Deferral Extension Requested 07/26/2016.  Denied per FDA letter dated 01/10/2017.
The final protocol milestone was missed because protocol finalization is dependent on the results of PMR 2755-1, for which the Final Report Submission date was extended. Deferral Extension Requested 05/15/2015. Denied per FDA letter dated 06/19/2015. The request was denied because it was premature to agree on the Final Report Submission date until PMR 2755-1 was closer to completion.
Per FDA letter dated 02/05/2016, this PMR has been fulfilled.
Original Final Report Due Date: 06/30/2015.  Per FDA letter dated 05/28/2014, Final Report due date extended to 06/30/2016.  Second Deferral Extension Granted per FDA letter dated 11/19/2014, Final Report due date extended to 8/17/2017. Study 905-CL-047 is ongoing, after 100 patients screened, with 66 patients (31 adolescents and 35 children) treated and 8 patients (4 adolescents and 4 children) withdrawn. The last patient started treatment on April 28, 2015; last subject last visit is expected by May 2016.
Reporting the enrollment in the study is ongoing with 18 patients randomized and 15 patients treated as of 10 February 2016.
The supplement was approved on 3/22/16. The PMR is delayed because final study report date for all NDAs specified in this PMR was missed.
Normosol™ R and Dextrose (Dextrose and Multiple Electrolytes Type 1)
Aminosyn™ II (Amino Acid and Electrolytes)
Normosol™ M and Dextrose (Dextrose and Multiple Electrolytes Type 1)
Potassium Chloride and Sodium Chloride in Dextrose
Isolyte® S in EXCEL® Plastic Container (Dextrose and Multiple Electrolytes)
Normosol®-R and Normosol®-R pH 7.4 (Multiple Electrolytes Type 1)
Potassium Chloride in Dextrose in Lactated Ringer's
Dextrose and Ringer's® in Plastic Container (Dextrose and Lactated Ringer's)
Magnesium Chloride and Potassium in Dextrose
SODIUM LACTATE INJECTION IN PLASTIC VIAL
Per FDA letter dated 03/18/2016, this PMR has been fulfilled.
Final report was due on March 31, 2014. The Sponsor states that since the ownership of this NDA changed so many times, the study is not done.
The final analysis plan submission due date was 06/30/15
The study completion milestone was missed due to difficulty in enrolling subjects. Additional sites currently being identified.
The study completion milestone was missed due to delayed submission of final protocol and ongoing enrollment.
The final protocol milestone was missed due to delayed submission of draft protocols. Draft protocols under FDA review
Original Final Report Due Date: 11/30/2016; Deferral Extension granted per FDA letter dated 10/08/2016.
The bi-annual interim report was submitted June 27, 2014. Trial completion due by September 2019
The protocol finalization milestone was missed because of ongoing discussion with FDA.
The study has not been initiated, but does not meet the criterion for delayed. Protocol submitted 8/14/15.
Deferral Extension Requested 10/07/2015.  Denied per FDA letter dated 03/02/2016.
Enrollment for the study is currently ongoing
The Final Protocol Submission milestone was missed because of ongoing discussions with FDA regarding study design. FDA determined that the applicant demonstrated sufficient justification for the delay.
The Final Report Submission milestone was missed because trial initiation was delayed due to protocol discussion with FDA and additional analyses were required that were expected to lengthen the report preparation time between trial completion and final report submission. FDA determined that the applicant demonstrated good cause for the delay.
The Final Report Submission milestone was missed because trial initiation was delayed due to protocol discussion with FDA and additional analyses were required that were expected to lengthen the report preparation time between trial completion and final report submission. FDA determined that the applicant demonstrated good cause for the delay.
JAVELIN PHARMACEUTICALS INC A WHOLLY OWNED SUDSIDIARY OF HOSPIRA INC
36 subjects have been enrolled, accrual completed on 7/14/16.
38 subjects have been enrolled, accrual completed on 7/14/16.
Plans to submit final study report per PMR timeline
Genvoya® (Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir Alafenamide)
MD-76R (Diatrizoate Meglumine and Diatrizoate Sodium)
Optiray™ 240, Optiray™ 300, Optiray™ 320, Optiray™ 350
Optiray™ 300 PBP, Optiray™ 320 PBP, Optiray™ 350 PBP (Ioversol)
The final study report was submitted to the FDA on 3/10/16.
Akynzeo® (Netupitant and Palonosetron Hydrochloride)
Enrollment for the study is currently ongoing. The Sponsor reports 78 subjects have been enrolled in Group 2 as of this reporting period.
Enrollment for the study is currently ongoing. The Sponsor reports 168subjects have been enrolled as of this reporting period.
Lumason® (Sulfur Hexafluoride Lipid-Type A Microspheres)
Product withdrawn from US market. Study terminated. Revised milestone letter issued 12/11/15. Final Report Submission September 2016.
Study 191622-137 is a Multicenter, randomized, double-blind, parallel-group, multiple-dose study. The study is currently ongoing with 30 subjects enrolled. Allergan plans to enroll approximately 108 subjects in this study.
Per FDA letter dated 07/29/2016, this PMR has been fulfilled.
Final protocol submission 18-DEC-15; agency comments received 08-FEB-16 teleconference (FDA and BMS) 12- FEB-16; missed milestone letter sent 07-MAR-16 Revised protocol sent 07-APR-16
Per FDA letter dated 07/15/2016, this PMR has been fulfilled
Onzetra™ and Xsail™ (Sumatriptan Succinate)
Odefsey® (Emtricitabine, Rilpivirine, and Tenofovir Alafenamide)
Allegra–D® Allergy and Congestion (Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride )
The study has not been initiated, but does not meet the criterion for delayed. Will begin in the future
Study terminated March 11, 2016. 295 subjects had been enrolled
Study terminated March 11, 2016. 475 subjects had been enrolled
Study terminated March 11, 2016. 457 subjects had been enrolled
Deferral Extension Requested 04/15/2016. Denied per FDA letter dated 04/25/2016.
Kombiglyze® XR (Saxagliptin and Metformin Hydrochloride)
Based on review of your April 27, 2015 submission, which you submitted with the intention of fulfilling PMR 2762-4, FDA has determined that have good cause for your failure to comply with the final protocol submission milestone of the original timetable.
Per FDA letter dated 05/20/2016, this PMR has been fulfilled.
Per FDA letter dated 07/13/2016, this PMR has been released.
Atripla® (Efavirenz, Emtricitabine, and Tenofovir Disoproxil Fumarate)
Original Final Report Due Date: 09/06/2016; Deferral Extension granted per FDA letter dated 12/09/2016.
The final study reports for the remaining products subject to the postmarketing requirement have not been submitted because the FDA was engaged in discussion with the applicant regarding the study design at the time the final study reports submission milestone was due and FDA determined that the applicant  demonstrated good cause for the delay.
Resectisol® (Mannitol Irrigation) in PIC™ (Plastic Irrigation Container)
Isolyte® H in EXCEL® Plastic Container (Dextrose and Multiple Electrolytes)
Isolyte® R in EXCEL® Plastic Container (Dextrose and Multiple Electrolytes)
Isolyte® E in EXCEL® Pastic Container (Dextrose and Multiple Electrolytes)
Isolyte® P in EXCEL® Pastic Container (Dextrose and Multiple Electrolytes)
Dextrose in Ringer's Injection in EXCEL® Plastic Container
Calcium Choride and Potassium Chloride in Dextrose
SMOFlipid™ (Soybean Oil, Medium Chain Triglycerides, Olive Oil, and Fish Oil)
The final report was submitted to FDA on 08/15/2016.
Complera® (Emtricitabine, Rilpivirine, and Tenofovir Disoproxil Fumarate)
Protocol submitted on March 31, 2015.The study has not begun but does not fit criteria for delay.
Obredon® (Hydrocodone Bitartrate and Guaifenesin)
PMR newly issued in FDA letter dated 11/25/2015 to replace 1944-2.
Glyxambi (Empagliflozin and Linagliptin) Tablets
The final protocol has not been submitted and final protocol milestone date has been missed.
Final Protocol Submission was due December 2015. No SPA agreement has been made.
The clinical trial completion date milestones have been missed and the final reports have not been submitted
Final Report was due March 2016. The study was initiated April 2016.
Per FDA letter dated 08/08/2016, this PMR has been released.
Delayed in meeting the due date for the Final Protocol Submission (Phase 2).
Entresto™ (Sacubutril and Valsartan) and Enalapril
Vantrela ER (hydrocodone bitartrate) tablets
The PK and Tolerability study component of PMR 2922-1 is being conducted via PMR 1932-2 and has been initiated. The Efficacy and Safety study component of PMR 2922-1 has not yet been initiated.
Final protocol submission date is September, 2017
The initiation of study CAIN457A2110 was delayed due to interactions between the Sponsor and the FDA in order to reach consensus on the study design. The revised schedule was acknowledged by FDA on September 29, 2015. The target enrollment is 25 patients in 2016.
The final protocol submission milestone date of 11/2015 was missed. Original protocol CAIN457A2324 was submitted 3/27/15 and discussions are currently ongoing. Initiation of CAIN457A2324 will begin upon FDA concurrence of the study design.
ColPrep Kit® (Sodium Sulfate, Potassium Sulfate, and Magnesium Sulfate)
Janumet® XR (Metformin Hydrochloride and Sitagliptin Phosphate)
Original Final Report Due Date: 09/30/2017; Deferral Extension granted per FDA letter dated 01/08/2015
Per FDA letter dated 10/06/2016, this PMR has been released.
The Final Protocol Submission milestone was missed because of ongoing discussion with FDA regarding study design. FDA determined that the applicant demonstrated good cause for the delay.
Protocol was due 9/2015. Sponsor did not submit protocol to the IND.
Original Final Report Due Date: 08/31/2019; Deferral Extension granted per FDA letter dated 07/08/2016.
Viekira Pak® (Ombitasvir, Paritaprevir, and Ritonavir; Dasabuvir)
Original Final Report Due Date: 08/31/2022; Deferral Extension granted per FDA letter dated 07/08/2016.
The final report milestone was missed, because sample testing was delayed due to assay development and time required to reconsent patients
Enrollment for 6-17 year olds completed as of 12/22/2015. Enrollment completion for 2-5 year olds targeted for 2Q2016.
The sponsor submitted on 11/23/15 proposed revised milestones dates due to their protocol study design negotiations with the agency.
MERCK SHARP AND DOHME CORP A SUBSIDIARY OF MERCK AND CO INC
The FDA is currently reviewing the protocol for Study B2411360 submitted on 19 November 2015. The projected first subject dose is for 6 January 2016. The timeline for this PMR is currently undergoing renegotiation with the FDA. Pfizer has proposed in a submission dated 23 November 2015 a new timeline for the completion of the study by no later than December 2016 with the submission of the final study report to be submitted no later than June 2017.
WYETH PHARMACEUTICALS INC A SUBSIDIARY OF PFIZER INC
S-010 submitted on June 18, 2015, but UF letter issued due to unpaid user fee
Supplement submitted, but FDA did not file.
Final study report was due in June, 2015, revised to November, 2015
The final protocol submission milestone was missed.
421/596 subjects completed the study. Study is completed, pending final study report.
GLAXOSMITHKLINE INTELLECTUAL PROPERTY DEVELOPMENT LTD ENGLAND
58/60 subjects completed the study. Study is completed, pending final study report.
111 subjects enrolled. Study is completed, pending final study report.
Deferral Extension Requested 11/10/2016.  Denied per FDA letter dated 12/20/2016.
Per FDA letter dated 03/10/2016, this PMR has been fulfilled.
Protocol was submitted 31-Oct-2014.Protocol amendment submitted 02-Apr-2015
VIFOR FRESENIUS MEDICAL CARE RENAL PHARMA FRANCE
Study terminated because the initial dose level tested exceeded the MTD. Report submitted September 15, 2009.
The final protocol milestone was missed, because the final protocol is still under negotiation.
The data included in the final report submission does not adequately fulfill the postmarketing requirement.The Original Final Report due date was not met.
The final report has not been submitted and the clinical trial completion date milestone has been missed.
The Final Protocol Submission milestone was missed, because of ongoing discussion with FDA regarding the study design and FDA determined that the applicant demonstrated “good cause” for the delay.
The final report milestone was missed, because the FDA was engaged in discussion with the applicant regarding the study design at the time the final report submission milestone was due and FDA determined that the applicant  demonstrated good cause for the delay.
Original Final Report Due Date: 12/31/2011; Deferral Extension granted per FDA letter dated 08/25/2015.
The interim report milestone was missed because of difficulties in accruing patients and FDA determined that the applicant demonstrated “good cause” for the delay.
Tuxarin™ ER (Codeine Phosphate and Chlorpheniramine Maleate)
The applicant has not reported the status.
Per FDA letter dated 08/15/2016, this PMR has been fulfilled.
Enrollment scheduled to begin September 2016.
Hycofenix® (Hydrocodone, Pseudoephedrine, and Guaifenesin)
Treximet® (Sumatriptan and Naproxen Sodium)
OTSUKA PHARMACEUTICAL DEVELOPMENT AND COMMERCIALIZATION INC
There are 68 subjects currently enrolled in the study of the 60-planned subject.
Final protocol missed pending further discussion with Agency in 3Q2016
Breo® Ellipta® (Fluticasone Furoate and Vilanterol)
Deferral Extension Requested 09/30/2016. Denied per FDA letter dated 11/14/2016.
The Sponsor reports that the study is being conducted.
Per FDA letter dated 09/14/2016, this PMR has been fulfilled.
The supplements were approved. The PMR is delayed because the final study report date for all NDAs specified in this PMR were missed
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Dextrose and Electrolyte® No 48 (Dextrose and Multiple Electrolytes Type 1)
Plasma-Lyte® 148 Injection in Plastic Container
Clinimix® Sulfite-Free (Amino Acids in Dextrose)
Plasma-Lyte® 56 in 5% Dextrose Injection in Plastic Container
Calcium Chloride and Magnesium Chloride in Dextrose
SODIUM CHLORIDE 3% & 5% INJ USP (PL 146)
LACTATED RINGER'S INJ IN PLASTIC(PL-146)
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAIN
Dextrose, Electrolytes, and Potassium Chloride
CLINIMIX E 2.75/10 SULFITE-FREE W/ ELECT
This PMC final report was due on 3/31/2006. FDA issued a not fulfilled letter on 4/28/2011. The sponsor is working with the FDA to discuss options to fulfill the PMC.
Per FDA letter dated 04/28/2016, this PMR has been fulfilled.
Ryzodeg® 70/30 (Insulin Degludec and Insulin Aspart)
The final protocol milestone of this post-marketing commitment was missed due to challenges developing an appropriate trial for the pediatric population.
105 patients out of the planned 120 patients have been enrolled into the study..
The final report was originally due Dec 31, 2013. On November 7, 2013, the milestones were revised to submit final follow-up data December 2017. The Sponsor is extending the follow-up period for the trial to obtain more survival information for the remaining patients on the trial. An updated clinical study report was submitted December 9, 2013. The final report with follow-up data will be submitted December 2017.
Enrollment in the adolescent cohort (Age 12 through less than <18 years old) was completed on 30 September 2014 and was evaluated by the study DSMB on 10 November 2014. Enrollment of subsequent age cohorts has not proceeded, as agreed between the FDA and Sponsor, and will not continue until FDA concurs with the study proceeding. Discussions between the FDA and Sponsor are ongoing.
Alphanate, Antihemophilic Factor/von Willebrand Factor Complex (Human)
Vivotif, Typhoid Vaccine Live Oral Ty21a
Prolastin; Prolastin-C, Alpha-1-Proteinase Inhibitor (Human)
Deferral Extension Requested December 16, 2013. Deferral Extension Granted per FDA letter dated December 30, 2013. A second Deferral Extension Requested November 10, 2015. Deferral Extension Denied per FDA letter dated December 21, 2015. The final report due date has passed with no final report received.
T.R.U.E. TEST, Thin-Layer Rapid Use Epicutaneous Patch Test
Emergent BioDefense Operations Lansing LLC
Fluzone; Fluzone High Dose; Fluzone Intradermal; Fluzone Quadrivalent, Influenza Virus Vaccine
FluMist; FluMist Quad, Influenza Vaccine Live, Intranasal
Aralast; Aralast NP, Alpha-1-Proteinase Inhibitor (Human)
“Good Cause justification was submitted on 06/10/2015 (STN 125062/450). Good Cause was granted per FDA letter dated 07/22/2015. The study completion date has passed and the study has not yet been completed.”
OCTAGAM, Immune Globulin Intravenous (Human)
The trial was initiated in April 2006; however, due to slow subject recruitment, Baxter sought guidance from the FDA in 2010 to revise the study protocol and complete the study in a timely manner. Based on discussions with FDA the protocol was amended (amendment 5: Version 02 Sep 2011).
Advate, Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method
Menactra, Meningococcal Groups (A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
CNJ-016, Vaccinia Immune Globulin Intravenous (Human)
GARDASIL, Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant
FLUARIX PMR Final Study Report to fulfill PMR #1 under /513 (STN 125127/833) submitted on 19-Jan-2017.
FLUARIX; FLUARIX Quadrivalent, Influenza Virus Vaccine
Pentacel, Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) Reconstituted with Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed Combined with Poliovirus Vaccine Inactivated
ACAM2000, Smallpox (Vaccinia) Vaccine, Live
STN 125163/405 fulfills postmarketing requirement #1 identified in the August 15, 2013 approval letter for STN 125163/253.
FluLaval; FluLaval Quadrivalent, Influenza Vaccine
STN 125163/405 fulfills postmarketing requirement #1 identified in the August 16, 2013 approval letter for STN 125163/254.
Good cause granted per FDA letter dated April 6, 2016. Study completion date has passed and the study has not yet been completed. Delayed with good cause determination. Due date was extended: Study Completion: January 31, 2017 Final Report Submission: September 30, 2017
Privigen, Immune Globulin Intravenous (Human), 10% Liquid
AFLURIA; Afluria Quadrivalent, Influenza Vaccine
Supplement STN 125254/642 submitted on October 31, 2016 to fulfill PMR#1 approved under STN 125254/565.
Cervarix, Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant
XYNTHA; XYNTHA SOLOFUSE, Antihemophilic Factor (Recombinant), Plasma/Albumin Free
Ixiaro, Japanese Encephalitis Vaccine, Inactivated, Adsorbed
The Final Study Report was submitted to FDA on June 30, 2015. Since this is a PREA PMR, the Final Study Report does not fulfill the PREA requirement.
Per FDA letter dated 02-Feb-2016, this PMR has been released.
Per FDA letter dated October 7, 2016, this PMR has been released.
Per FDA letter dated 02-Feb-2016, this PMR has been fulfilled.
Adenovirus Type 4 and Type 7 Vaccine, Live, Oral
The company submitted the Final Study report on Feb 28, 2013 under 125297/46. Since this is a PREA PMR, the Final Study Report does not fulfill the PREA requirement.
Final Study Report was submitted as 125297/49 on July 31, 2013. Since this is a PREA PMR, the Final Study Report does not fulfill the PREA requirement.
The study completion (establishment of the pregnancy registry) date has passed and the study has not yet been completed.
Submission of the complete final study report is still delayed for this agreed upon PMC due to issues with the testing of the samples in the study for the HPV vaccine. Completed study report expected December 2017.
Menveo, Meningococcal (Groups A, C, Y, and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine
Prevnar 13, Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)
The Final Study Report expected December 31, 2017. Delay due to delay in receiving data from CDC database and was found an acceptable delay from submission of March 2, 2016. Delayed. Study is Ongoing, but behind original schedule. Final Study Report expected on time with revised schedule of December 31, 2017.
Deferral Extension Granted per FDA letter dated 01 February 2016. The final protocol due date has passed with no final protocol received.
Hiberix, Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)
MENHIBRIX, Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine
Bivigam, Immune Globulin Intravenous (Human)
Per FDA letter dated October 7, 2016, this PMR/PMC has been released
TRETTEN, Coagulation Factor XIII A-Subunit (Recombinant)
GINTUIT, Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen
HYQVIA, Immune Globulin Infusion (Human), 10% with Recombinant Human Hyaluronidase
Per FDA letter dated 23-May-2016, this PMR/PMC has been fulfilled.
Flucelvax; Flucelvax Quadrivalent, Influenza Vaccine
PMR Final Study Report submitted 30-Nov-2016.
Per FDA letter dated May 23, 2016, this PMR/PMC has been released.
Deferral Extension Requested 06/29/2016. Deferral extension Granted per FDA letter dated 08/10/2016.
OCTAPLAS, Pooled Plasma (Human), Solvent/Detergent Treated
Per FDA letter dated September 9, 2016, this PMR has been fulfilled.
Q-Pan, Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted
Per FDA letter dated September 9, 2016, this PMR has been released.
Kcentra, Prothrombin Complex Concentrate (Human)
Sponsor has not submitted an acceptable protocol.
The final protocol has been submitted but no subjects have yet entered the trial.
IXINITY, Coagulation Factor IX (Recombinant)
ALPROLIX, Coagulation Factor IX (Recombinant), Fc Fusion Protein
RIXUBIS, Coagulation Factor IX (Recombinant)
BAT, Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) - (Equine)
Deferral Extension Requested 05/12/2016. Deferral Extension Granted per FDA letter dated 7/15/2016. Study is ongoing.
ORALAIR, Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract
GRASTEK, Timothy Grass Pollen Allergen Extract
RAGWITEK, Short Ragweed Pollen Allergen Extract
ELOCTATE, Antihemophilic Factor (Recombinant), Fc Fusion protein
RUCONEST, C1 Esterase Inhibitor (Recombinant)
Gardasil 9, Human Papillomavirus 9-valent Vaccine, Recombinant
OBIZUR, Antihemophilic Factor (Recombinant), Porcine Sequence
Deferral Extension Requested 5/31/2016. Deferral Extension Granted per FDA letter dated 09/08/2016. Study is ongoing.
The final report (STN 125546/53) was submitted to FDA on February 12, 2016.
The study has not been initiated but does not meet the criterion for delayed.
Nuwiq, Antihemophilic Factor (Recombinant), rAHF
Anthrasil, Anthrax Immune Globulin Intravenous (Human)
Per FDA letter dated 22-Dec-2016, this PMR/PMC is fulfilled.
ADYNOVATE, Antihemophilic Factor (Recombinant), PEGylated
KOVALTRY, Antihemophilic Factor (Recombinant), Full Length