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Non-Compliance Letters under 505B(d)(1) of the Federal Food, Drug, and Cosmetic Act

In accordance with section 505B(d)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the following table identifies drug and biological products for which the sponsor has received a Non-Compliance letter and provides links to the Non-Compliance letter and sponsor’s response (with redactions for trade secret or confidential commercial information). These letters have been issued under provisions of the Pediatric Research Equity Act (PREA), which amended the FD&C Act, and are commonly referred to as “PREA Non-Compliance letters.

Consistent with section 505B(d)(1) of the FD&C Act, FDA has issued a PREA Non-Compliance letter to a sponsor if it failed to submit within the required timeframe a required pediatric assessment or report of a molecularly targeted pediatric cancer investigation (as appropriate) (usually in the form of a supplemental application that includes proposed labeling). FDA has also issued such a letter if a sponsor failed to request approval for a pediatric formulation as described in section 505B(a) or 505B(b) of the FD&C Act. Consistent with section 505B(d)(1), FDA has also made publicly available on FDA’s website the PREA Non-Compliance letter and sponsor’s response with certain redactions.

If a sponsor has requested a deferral extension in accordance with section 505B(a)(4)(B)(i), or submitted a waiver request in accordance with section 505B(a)(5), by the due date of the pediatric assessment or the report of the molecularly targeted pediatric cancer investigation, FDA has not issued a PREA Non-Compliance letter unless FDA subsequently denied the deferral extension or waiver request. 

Further, if FDA has determined that a PREA Non-Compliance letter was issued to the sponsor in error (e.g., a waiver was granted prior to the due date of the pediatric assessment or report of the molecularly targeted pediatric cancer investigation), then neither the PREA Non-Compliance letter nor the sponsor’s response have been posted.

Where the sponsor has fulfilled or has otherwise been released from the requirement to conduct one or more pediatric assessments or molecularly targeted cancer investigations, FDA has added the date the requirement was fulfilled or released to the last column of the table. For more information about the current status of a specific PREA postmarketing requirement (i.e., a required pediatric assessment or molecularly targeted pediatric cancer investigation that was deferred until some point after the product’s approval), please visit Postmarket Requirements and Commitments.

*Persons with disabilities having problems accessing these PDF file(s) may call (301) 796-3634 for assistance.

N=56

Sponsor Product Date of Non-Compliance Letter Date of Sponsor's Response Comments
Vanda Pharmaceuticals, Inc. Fanapt (iloperidone) tablets 10/1/20 11/13/20  
Salix Pharmaceuticals, Inc. Trulance (plecanatide) tablet 9/17/20 10/20/20  
Helsinn Healthcare SA Aloxi (palonosetron HCl) Injection 4/11/13 5/2/13 Fulfilled (5/27/14)
Helsinn Healthcare SA
Aloxi (palonosetron HCl) Injection
4/11/13 5/2/13 Fulfilled (5/27/14)
Incline Therapeutics, Inc.
Ionsys (fentanyl iontophoretic transdermal system)
4/12/13 5/9/13 Released (8/30/19)
Vicuron Holdings LLC
Eraxis (anidulafungin) Powder for Injection
4/12/13 5/23/13 Fulfilled (9/22/20)
Valeant International Bermuda
Xerese (acyclovir and hydrocortisone) Cream 5%/1%
5/7/13 6/21/13 Fulfilled (1/22/14)
Portola Pharmaceuticals, Inc. Bevyxxa (betrixaban) 8/14/20 10/09/20  
Currax Pharmaceuticals LLC  Onzetra Xsail (sumatriptan nasal powder) 11 mg 8/12/20 9/15/20  
Neos Therapeutics, Inc Adzenys XR-ODT (amphetamine extended-release orally disintegrating tablets) 7/28/20 8/18/20  
Mylan Ireland Limited Arixtra (fondaparinux sodium injection) solution 4/27/20 6/16/20  
Rempex Pharmaceuticals, Inc. Vabomere (meropenem-vaborbactam), Powder for Injection, 1 gram/vial 5/01/20 5/15/20  
Tris Pharma, Inc. Dyanavel XR (amphetamine) extended-release oral suspension 3/05/20 4/23/20  
Arbor Pharmaceuticals, LLC
Edarbi (azilsartan medoxomil) Tablets, 40 mg & 80 mg
2/10/20 3/26/20  
Teva Pharmaceutical Industries, Ltd.
ArmonAir RespiClick (fluticasone propionate/salmeterol xinafoate inhalation powder
1/30/20 2/19/20  
Teva Pharmaceutical Industries, Ltd.
AirDuo Digihaler/AirDuo RespiClick (fluticasone propionate/salmeterol xinafoate inhalation powder)
1/30/20 2/19/20  
Akebia Therapeutics

Auryxia (ferric citrate) Tablets

1/31/20 03/13/20  
Assertio Therapeutics, Inc.
 Zipsor (diclofenac potassium) liquid filled-capsules)
11/05/19 12/26/19  
Supernus Pharmaceuticals, Inc Trokendi XR (topiramate) extended-release capsules 12/09/19 No Response (2/8/20)  
Cumberland Pharmaceuticals, Inc. Vibativ (televancin) for Injection, 250 mg & 750 mg 12/12/19 01/15/20  
UCB. Inc. Cimzia (certolizumab pegol)

12/20/19

01/31/20  
AstraZeneca Pharmaceuticals LP Nexium (esomeprazole magnesium) for delayed release oral suspension 08/21/19 10/3/19  
Supernus Pharmaceuticals Trokendi XR (topiramate) extended-release capsules 10/2/19 11/8/19  
Ferring Pharmaceuticals, Inc. Prepopik (citric acid, magnesium oxide, and sodium picosulfate) 10/4/19 11/19/19  
Braintree Laboratories SUPREP Bowel Prep Kit (sodium sulfate, potassium sulfate and magnesium sulfate) Oral Solution 7/16/18 8/27/18 Fulfilled(8/5/20)
Purdue Pharma Palladone (hydromorphone hydrochloride extended release) Capsules 4/10/13 5/8/13 (PDF - 591KB)* Released
(1/24/17)
Genzyme Renvela (sevelamer carbonate) Tablets 5/24/13* Fulfilled
(12/14/16)
 
Genzyme Renvela (sevelamer carbonate) for Oral Suspension 4/11/13 5/24/13 (PDF - 901KB)* Fulfilled
(12/14/16)
Genzyme Hectorol (doxercalciferol capsules) 4/12/13 5/14/13 (PDF - 1.4 MB)*
8/15/13 (PDF - 738K B)*
 
Amedra Pharmaceuticals Twinject/Adrenaclick (epinephrine injection, USP 1:1000) 0.15 mg and 0.3 mg 5/13/13 6/27/13 (PDF - 828 KB)* Fulfilled
(1/30/14)
The Medicines Company Cleviprex (clevidipine) IV emulsion 0.5 mg/mL 5/14/13 6/10/13 (PDF - 775 KB)*  
Salix Pharmaceuticals Apriso (mesalamine) Capsules 6/10/13 07/25/13 (PDF - 75KB)*  
Sunovion Pharmaceuticals Xopenex (levalbuterol HCl) Inhalation Solution 6/13/13 7/24//13 (PDF - 246KB)* Fulfilled
(1/22/15)
Pfizer Protonix I.V. (pantoprazole sodium) for Injection 6/14/13 7/26/13 (PDF -  235KB)*  
Pfizer Protonix I.V. (pantoprazole sodium) for Injection 6/14/13 7/26/13 (PDF - 235 KB)*  
Depomed, Inc. Cambia (diclofenac potassium for oral solution) 7/03/13 8/14/13 (PDF -1 MB) Released & Replaced (6/20/17) 
Tris Pharma Nexiclon (clonidine) Extended Release Oral Suspension 10/03/13 No Response (12/2/13)  
Braintree Laboratories HalfLytely and Bisacodyl Tablet Bowel Prep Kit (PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution and bisacodyl delayed-release tablet) 3/06/14 4/11/14 (PDF - 820 K B)  
Braintree Laboratories Axid (nizatidine) Oral Solution 4/02/14 5/14/14 (PDF -4 72 KB)* Released (8/8/17)
BioAlliance Pharma Oravig (miconazole) Buccal Tablets, 50 mg 4/04/14 5/9/14 (PDF - 4.8 MB)*  
Egalet US, Inc. (formerly Luitpold Pharmaceuticals, Inc.) Sprix (ketorolac tromethamine) Nasal Spray 6/12/14 Supplement (6/18/14) User fee was not paid
Depomed, Inc. Zipsor (diclofenac potassium) Liquid-Filled Capsules 1/28/15 2/26/15 (PDF - 4.8 MB)*  
Acorda Therapeutics, Inc. Zanaflex (tizanidine) Capsules 3/19/15 4/24/15 (PDF - 2.7 MB)  
Meridian Medical Technologies, Inc. DuoDote (atropine and pralidoxime chloride injection) Auto-Injector 5/20/15 7/1/15 (PDF -7 69 KB)*  
Supernus Pharmaceuticals, Inc. Trokendi XR (topiramate extended release capsules) 9/29/15 11/12/15 (PDF -308 KB)*  
Merck Sharpe & Dohme Corp. Cubicin (daptomycin for injection) 500 mg/vial 3/03/16 4/15/16 (PDF - 1.2 MB) Fulfilled (3/29/17)
Purdue Pharmaceutical Products LP Dilaudid & Dilaudid HP Injection 4/21/16 6/23/16 (PDF - 88 KB)  
Mallinckrodt Inc. Xartemis XR (oxycodone HCl and acetaminophen) Extended-Release Tablets, 7.5 mg/325 mg 4/25/16 7/15/16 (PDF - 498 KB)* A deferral extension was requested after the fact & granted 9/1/16
Guerbet LLC Dotarem (gadoterate meglumine) Injection 7/07/16 8/15/16 (PDF - 1.48 MB)*  
Depomed, Inc. Zipsor (diclofenac potassium) Liquid-Filled Capsules 7/07/16 8/1/16 (PDF - 256 KB)*  
Valeant Pharmaceuticals North America LLC Uceris (budesonide) Extended-Release Tablets, 9 mg 10/04/16 11/18/16 PDF - 67 KB)  
Supernus Pharmaceuticals, Inc. Oxtellar XR (oxcarbazepine) Extended-Release Tablets 1/12/17 3/10/17 (PDF - 681 KB)*  
Pfizer Advil (ibuprofen sodium) tablets, 256 mg 6/12/17 7/21/17  (PDF - 90 KB)  
Iroko Pharmaceuticals Zorvolex (diclofenac) Capsules 1-25-18 (PDF - 91 KB) 3-1-18 (PDF - 363 KB)
3-7-18 (PDF - 359KB)
 
Iroko Pharmaceuticals Tivorbex (indomethacin) Capsules 6-19-18 (PDF - 91 KB) 7-10-18 (PDF - 363 KB)  
Vistapharm Inc. Oxycodone Hydrochloride Oral Solution 7-9-19 (PDF - 36 KB) 8-22-19 (PDF - 86 KB)
11-6- 19 (PDF - 714 KB)
 

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