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.


SponsorProductDate of Non-Compliance LetterDate of Sponsor's ResponseComments
Purdue PharmaPalladone (hydromorphone hydrochloride extended release) Capsules4/10/135/8/13 (PDF - 591KB)*Released
GenzymeRenvela (sevelamer carbonate) Tablets5/24/13*Fulfilled
GenzymeRenvela (sevelamer carbonate) for Oral Suspension4/11/135/24/13 (PDF - 901KB)*Fulfilled
GenzymeHectorol (doxercalciferol capsules)4/12/135/14/13 (PDF - 1.4 MB)*
8/15/13 (PDF - 738K B)*
Amedra PharmaceuticalsTwinject/Adrenaclick (epinephrine injection, USP 1:1000) 0.15 mg and 0.3 mg5/13/136/27/13 (PDF - 828 KB)*Fulfilled
The Medicines CompanyCleviprex (clevidipine) IV emulsion 0.5 mg/mL5/14/136/10/13 (PDF - 775 KB)* 
Salix PharmaceuticalsApriso (mesalamine) Capsules6/10/1307/25/13 (PDF - 75KB)* 
Sunovion PharmaceuticalsXopenex (levalbuterol HCl) Inhalation Solution6/13/137/24//13 (PDF - 246KB)*Fulfilled
PfizerProtonix I.V. (pantoprazole sodium) for Injection6/14/137/26/13 (PDF -  235KB)* 
PfizerProtonix I.V. (pantoprazole sodium) for Injection6/14/137/26/13 (PDF - 235 KB)* 
Depomed, Inc.Cambia (diclofenac potassium for oral solution)7/03/138/14/13 (PDF -1 MB)Released & Replaced (6/20/17) 
Tris PharmaNexiclon (clonidine) Extended Release Oral Suspension10/03/13No Response (12/2/13) 
Braintree LaboratoriesHalfLytely and Bisacodyl Tablet Bowel Prep Kit (PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution and bisacodyl delayed-release tablet)3/06/144/11/14 (PDF - 820 K B) 
Braintree LaboratoriesAxid (nizatidine) Oral Solution4/02/145/14/14 (PDF -4 72 KB)*Released (8/8/17)
BioAlliance PharmaOravig (miconazole) Buccal Tablets, 50 mg4/04/145/9/14 (PDF - 4.8 MB)* 
Egalet US, Inc. (formerly Luitpold Pharmaceuticals, Inc.)Sprix (ketorolac tromethamine) Nasal Spray6/12/14Supplement (6/18/14)User fee was not paid
Depomed, Inc.Zipsor (diclofenac potassium) Liquid-Filled Capsules1/28/152/26/15 (PDF - 4.8 MB)* 
Acorda Therapeutics, Inc.Zanaflex (tizanidine) Capsules3/19/154/24/15 (PDF - 2.7 MB) 
Meridian Medical Technologies, Inc.DuoDote (atropine and pralidoxime chloride injection) Auto-Injector5/20/157/1/15 (PDF -7 69 KB)* 
Supernus Pharmaceuticals, Inc.Trokendi XR (topiramate extended release capsules)9/29/1511/12/15 (PDF -308 KB)* 
Merck Sharpe & Dohme Corp.Cubicin (daptomycin for injection) 500 mg/vial3/03/164/15/16 (PDF - 1.2 MB)Fulfilled (3/29/17)
Purdue Pharmaceutical Products LPDilaudid & Dilaudid HP Injection4/21/166/23/16 (PDF - 88 KB) 
Mallinckrodt Inc.Xartemis XR (oxycodone HCl and acetaminophen) Extended-Release Tablets, 7.5 mg/325 mg4/25/167/15/16 (PDF - 498 KB)*A deferral extension was requested after the fact & granted 9/1/16
Guerbet LLCDotarem (gadoterate meglumine) Injection7/07/168/15/16 (PDF - 1.48 MB)* 
Depomed, Inc.Zipsor (diclofenac potassium) Liquid-Filled Capsules7/07/168/1/16 (PDF - 256 KB)* 
Valeant Pharmaceuticals North America LLCUceris (budesonide) Extended-Release Tablets, 9 mg10/04/1611/18/16 PDF - 67 KB) 
Supernus Pharmaceuticals, Inc.Oxtellar XR (oxcarbazepine) Extended-Release Tablets1/12/173/10/17 (PDF - 681 KB)* 
PfizerAdvil (ibuprofen sodium) tablets, 256 mg6/12/177/21/17  (PDF - 90 KB) 
Iroko PharmaceuticalsZorvolex (diclofenac) Capsules1-25-18 (PDF - 91 KB)3-1-18 (PDF - 363 KB)
3-7-18 (PDF - 359KB)
Iroko PharmaceuticalsTivorbex (indomethacin) Capsules6-19-18 (PDF - 91 KB)7-10-18 (PDF - 363 KB) 

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