Drugs

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

N=25

Sponsor Product Non-Compliance Letter Sponsor's Response Comments
Purdue Pharma Palladone (hydromorphone hydrochloride extended release) Capsules 4/10/13 (PDF-40KB) 5/8/13 (PDF-591KB)*  
Genzyme Renvela (sevelamer carbonate) Tablets 4/11/13 (PDF-37KB) 5/24/13 (PDF-901KB)*  
Genzyme Renvela (sevelamer carbonate) for Oral Suspension 4/11/13 (PDF-37KB) 5/24/13 (PDF-901KB)*  
Genzyme Hectorol (doxercalciferol capsules) 4/12/13 (PDF-37KB) 5/14/13 (PDF-1.4MB)*
8/15/13 (PDF-738KB)*
 
Amedra Pharmaceuticals Twinject/Adrenaclick (epinephrine injection, USP 1:1000) 0.15 mg and 0.3 mg 5/13/13 (PDF-37KB) 6/27/13 (PDF-828KB)* Fulfilled (1/30/14)
The Medicines Company Cleviprex (clevidipine) IV emulsion 0.5 mg/mL 5/14/13 (PDF-37KB) 6/10/13 (PDF-775KB)*  
Salix Pharmaceuticals Apriso (mesalamine) Capsules 6/10/13 (PDF-37KB) 7/25/13 (PDF-775KB)*  
Sunovion Pharmaceuticals Xopenex (levalbuterol HCl) Inhalation Solution 6/13/13 (PDF-36KB) 7/24//13 (PDF- 246KB)* Fulfilled (1/22/15)
Pfizer Protonix I.V. (pantoprazole sodium) for Injection 6/14/13 (PDF-36KB) 7/26/13 (PDF- 235KB)*  
Pfizer Protonix I.V. (pantoprazole sodium) for Injection 6/14/13 (PDF-36KB) 7/26/13 (PDF- 235KB)*  
Nautilus Neurosciences Cambia (diclofenac potassium for oral solution) 7/3/13 (PDF-33KB) 8/14/13 (PDF-1MB)  
Tris Pharma Nexiclon (clonidine) Extended Release Oral Suspension 10/3/13 (PDF-112KB) 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) 3/6/14 (PDF-28KB) 4/11/14 (PDF-820KB)  
Braintree Laboratories Axid (nizatidine) Oral Solution 4/2/14 (PDF-28KB) 5/14/14 (PDF-472KB)*  
BioAlliance Pharma Oravig (miconazole) Buccal Tablets, 50 mg 4/4/14 (PDF - 27KB) 5/9/14 (PDF -4.8MB)*  
Egalet US, Inc. (formerly Luitpold Pharmaceuticals, Inc.) New! Sprix (ketorolac tromethamine) Nasal Spray 6/12/14 (PDF - 87KB) Supplement (6/18/14) User fee was not paid
Depomed, Inc. Zipsor (diclofenac potassium) Liquid-Filled Capsules 1/28/15 (PDF - 31KB) 2/26/15 (PDF -4.8MB)*  
Acorda Therapeutics, Inc. Zanaflex (tizanidine) Capsules 3/19/15 (PDF - 126KB) 4/24/15 (PDF - 2.7MB)  
Meridian Medical Technologies, Inc. DuoDote (atropine and pralidoxime chloride injection) Auto-Injector 5/20/15 (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/vial 3/3/16 (PDF - 126KB) 4/15/16 (PDF - 1.2MB)  
Purdue Pharmaceutical Products LP Dilaudid & Dilaudid HP Injection 4/21/16 (PDF - 98KB) 6/23/16 (PDF - 88KB)  
Mallinckrodt Inc. Xartemis XR (oxycodone HCl and acetaminophen) Extended-Release Tablets, 7.5 mg/325 mg 4/25/16 (PDF - 126KB)* 7/15/16 (PDF - 498 KB)* A deferral extension was requested after the fact & granted 9/1/16. 
Guerbet LLC New! Dotarem (gadoterate meglumine) Injection 7/7/16 (PDF - 118KB)* 8/15/16 (PDF - 1.48MB)*  
Depomed, Inc. New! Zipsor (diclofenac potassium) Liquid-Filled Capsules 7/7/16 (PDF - 122KB)* 8/1/16 (PDF - 256KB)*  


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Page Last Updated: 09/06/2016
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