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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, as amended by the Food and Drug Administration Safety and Innovation Act of 2012 (Pub. L. No. 112-144), the following table identifies drug and biologic products for which the sponsor has received a PREA Non-Compliance letter and provides links to the PREA Non-Compliance letter and sponsor response (with redactions for trade secret or confidential commercial information). Per the requirements of the law, this website will be updated whenever we have new information to add.

Section 505B(d)(1) requires FDA to send a PREA Non-Compliance letter to sponsors who have failed to submit their pediatric assessments required under PREA by the final due date, have failed to seek or obtain a deferral or deferral extension, or have failed to request approval for a required pediatric formulation. Section 505B(d)(1) further requires FDA to post the PREA Non-Compliance letter and sponsor’s response.

If a sponsor has requested a deferral extension in accordance with 505B(a)(3)(B)(i), FDA does not intend to post a PREA Non-Compliance letter or sponsor’s response until we have determined whether to grant or deny the deferral extension request. If we have granted a sponsor’s deferral extension request and the extended deferral date has not yet passed, neither a PREA Non-Compliance letter nor a sponsor’s response will be posted.

If a sponsor has requested a waiver in accordance with 505B(a)(4), FDA does not intend to post a PREA Non-Compliance letter or sponsor's response until we have determined whether the letter was issued in error. If we have granted a sponsor's waiver request then the PREA Non-Compliance letter and sponsor's response will not be posted.

When the sponsor fulfills or is otherwise released from the requirement to conduct the study(ies), FDA will add the date the requirement is fulfilled or released to the last column of the table.

For more information about the current status of a specific PREA postmarketing requirement (pediatric study), please visit Postmarket Requirements and Commitments.

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


Sponsor Product Date of Non-Compliance Letter Date of Sponsor's Response Comments
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)


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  
Purdue Pharma Palladone (hydromorphone hydrochloride extended release) Capsules 4/10/13 5/8/13 (PDF - 591KB)* Released
Genzyme Renvela (sevelamer carbonate) Tablets 5/24/13* Fulfilled
Genzyme Renvela (sevelamer carbonate) for Oral Suspension 4/11/13 5/24/13 (PDF - 901KB)* Fulfilled
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
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
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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