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).

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 http://www.accessdata.fda.gov/scripts/cder/pmc/index.cfm


SponsorProductNon-Compliance LetterSponsor's ResponseComments
Purdue PharmaPalladone (hydromorphone hydrochloride extended release) Capsules4/10/13 (PDF-40KB)5/8/13 (PDF-591KB)* 
GenzymeRenvela (sevelamer carbonate) Tablets4/11/13 (PDF-37KB)5/24/13 (PDF-901KB)* 
GenzymeRenvela (sevelamer carbonate) for Oral Suspension4/11/13 (PDF-37KB)5/24/13 (PDF-901KB)* 
GenzymeHectorol (doxercalciferol capsules)4/12/13 (PDF-37KB)5/14/13 (PDF-1.4MB)*
8/15/13 (PDF-738KB)*
Amedra PharmaceuticalsTwinject/Adrenaclick (epinephrine injection, USP 1:1000) 0.15 mg and 0.3 mg5/13/13 (PDF-37KB)6/27/13 (PDF-828KB)*Fulfilled (1/30/14)
The Medicines CompanyCleviprex (clevidipine) IV emulsion 0.5 mg/mL5/14/13 (PDF-37KB)6/10/13 (PDF-775KB)* 
Salix PharmaceuticalsApriso (mesalamine) Capsules6/10/13 (PDF-37KB)7/25/13 (PDF-775KB)* 
Sunovion PharmaceuticalsXopenex (levalbuterol HCl) Inhalation Solution6/13/13 (PDF-36KB)7/24//13 (PDF- 246KB)*Fulfilled (1/22/15)
PfizerProtonix I.V. (pantoprazole sodium) for Injection6/14/13 (PDF-36KB)7/26/13 (PDF- 235KB)* 
PfizerProtonix I.V. (pantoprazole sodium) for Injection6/14/13 (PDF-36KB)7/26/13 (PDF- 235KB)* 
Nautilus NeurosciencesCambia (diclofenac potassium for oral solution)7/3/13 (PDF-33KB)8/14/13 (PDF-1MB) 
Tris PharmaNexiclon (clonidine) Extended Release Oral Suspension10/3/13 (PDF-112KB)No 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)3/6/14 (PDF-28KB)4/11/14 (PDF-820KB) 
Braintree LaboratoriesAxid (nizatidine) Oral Solution4/2/14 (PDF-28KB)5/14/14 (PDF-472KB)* 
BioAlliance PharmaOravig (miconazole) Buccal Tablets, 50 mg4/4/14 (PDF - 27KB)5/9/14 (PDF -4.8MB)* 
Depomed, Inc.Zipsor (diclofenac potassium) Liquid-Filled Capsules1/28/15 (PDF - 31KB)2/26/15 (PDF -4.8MB)* 
Acorda Therapeutics, Inc. New!Zanaflex (tizanidine) Capsules3/19/15 (PDF - 126KB)4/24/15 (PDF - 2.7MB) 
Meridian Medical Technologies, Inc.DuoDote (atropine and pralidoxime chloride injection) Auto-Injector5/20/15 (PDF - 31KB)7/1/15 (PDF -769KB)* 
Supernus Pharmaceuticals, Inc.Trokendi XR (topiramate extended release capsules)9/29/15 (PDF -119KB)11/12/15 (PDF -308KB)* 
Merck Sharpe & Dohme Corp.Cubicin (daptomycin for injection) 500 mg/vial3/3/16 (PDF - 126KB)4/15/16 (PDF - 1.2MB) 

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

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