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
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.
Find 2014 and older
Non-Compliance Letters under 505B(d)(1) of the Federal Food, Drug, and Cosmetic Act
in the FDA Archive
N=126
| Sponsor | Product | Date of Non-Compliance Letter | Date of Sponsor's Response | Comments |
|---|---|---|---|---|
| Assertio Therapeutics, Inc. | Cambia (diclofenac potassium) powder for oral solution | 09/28/22 | 12/07/22 | |
| Genus Lifesciences Inc. | Tivorbex (indomethacin) capsules | 09/29/22 | No Response | |
| Primus Pharmaceuticals Inc | Sernivo (betamethasone dipropionate) topical spray | 03/16/22 | 04/22/22 | |
| Salix Pharmaceuticals Inc | Trulance (plecanatide) tablets | 06/23/22 | 08/03/22 | |
| Midatech Pharma US Inc |
Zuplenz (ondansetron) oral soluble film |
08/06/18 | 09/06/18 | |
| CMP Development, LLC |
CaroSpir (spironolactone) Oral Suspension |
11/05/21 | 12/10/21 | Released & Replaced (1/13/22) |
| Chartwell Pharmaceuticals, LLC |
LymePak (doxycycline hyclate) Tablet |
11/17/21 | No Response (1/16/2022) | |
| Benuvia Therapeutics, Inc |
Syndros (dronabinol) Oral Solution |
12/16/21 | 11/28/22 | |
| SK Life Science, Inc. |
Xcopri (cenobamate) Tablet |
12/17/21 | 01/28/22 | Fulfilled (3/2/23) |
| Validus Pharmaceuticals, LLC |
Equetro (carbamazepine) Extended-Release Capsules 100mg, 200 mg, and 300 mg |
07/09/18 | 7/25/18 | Comments = Released (11/2/18) |
| Galderma Laboratories, L.P. |
Vectical (calcitriol) Ointment, 3 mcg/g |
01/10/18 | 1/29/18 | Comments = Fulfilled (7/17/20) |
| Salix Pharmaceuticals, Inc. |
Xifaxan (rifaximin) tablets, 200 mg and 550 mg |
08/21/19 | 10/04/19 | |
| Bausch Health US, LLC |
Aplenzin (bupropion hydrobromide) extended-release tablets 174 mg, 348 mg, 522 mg |
03/19/19 | 04/19/19 | |
| Endo Pharmaceuticals Inc. | Opana ER (oxymorphone hydrochloride) extended-release tablets | 10/12/21 | 11/24/21 | |
| Vifor Pharma Inc. | Veltassa (patiromer) powder for oral suspension | 10/15/21 | 11/26/21 | |
| Supernus Pharmaceuticals Inc. | Oxtellar XR (oxcarbazepine) extended-release tablets | 10/15/21 | No Response | |
| Orexigen Therapeutics, Inc. | Contrave (naltrexone hydrochloride/bupropion hydrochloride) extended-release tablets | 04/04/17 | 05/09/17 | Fulfilled (10/30/17) |
| AMAG Pharmaceuticals, Inc. | Feraheme (ferumoxytol) injection | 04/07/17 | 05/05/17 | |
| Sovereign Pharmaceuticals, LLC | Obredon (hydrocodone bitartrate and guaifenesin) Oral Solution | 04/11/17 | 05/01/17 | Released (10/30/17) |
| West-Ward Pharmaceutical Corp. | phenylephrine hydrochloride injection, USP, 10 mg/mL | 06/08/17 | 07/21/17 | |
| Mayne Pharma LLC | Sorilux (calcipotriene) foam, 0.005% | 07/14/17 | 08/11/17 | Fulfilled (5/6/19) |
| Midatech Pharma US, Inc. | Zuplenz (ondansetron) oral soluble film | 10/03/16 | 11/15/16 | |
| Depomed, Inc. | Cambia (diclofenac) powder for oral solution | 01/09/17 | 02/15/17 | Released & Replaced (6/20/17) |
| Celgene Corporation | Otezla (apremilast) tablets | 02/06/17 | 03/13/17 | |
| Insys Development Company, Inc. | Syndros (dronabinol oral solution) | 02/07/17 | 02/17/17 | Fulfilled (10/18/17) |
| Vernalis (R&D) Limited | Moxatag (amoxicillin extended-release) tablets | 03/08/17 | No Response | Released (11/2/17) |
| Salix Pharmaceuticals, Inc. | Xifaxan (rifaximin) tablets | 09/13/21 | 10/27/21 | |
| Zyla Life Sciences US, Inc. | Sprix (ketorolac tromethamine) nasal spray | 09/08/21 | 11/3/21 | |
| KVK-Tech, Inc. | Apadaz (benzhydrocodone and acetaminophen) tablets | 09/07/21 | 09/16/21 | |
| Belcher Pharmatech LLC | esomeprazole strontium capsule | 08/04/21 | 10/01/21 | |
| Takeda Pharmaceuticals USA, Inc. | Brintellix (vortioxetine) Tablets | 03/10/15 | 03/23/15 | Fulfilled (4/24/17) |
| Ipsen Biopharm Limited | Dysport for Injection (abobotulinumtoxinA) | 09/23/15 | 10/30/15 | Fulfilled (7/29/16) |
| Hospira, Inc. | Precedex (dexmedetomidine hydrochloride) | 09/25/15 | 11/09/15 | |
| Lehigh Valley Technologies, Inc. | oxycodone hydrochloride capsules, 5 mg, & oral solution, 100 mg/5 mL | 12/08/15 | 02/02/16 | |
| Roxane Laboratories, Inc. | morphine sulfate solution & tablets | 02/05/16 | 03/11/16 | Fulfilled (6/2/21) |
| Forest Laboratories, Inc. | Rectiv (nitroglycerin) Ointment 0.4% | 06/25/14 | 08/06/14 | Released (3/27/15) |
| Cumberland Pharmaceuticals Inc. | Caldolor (ibuprofen) Injection, 400 mg/4 mL (100 mg/mL) and 800 mg/8 mL (100 mg/mL) | 07/15/14 | 08/20/14 | Released & Replaced (12/24/14) |
| Digestive Care, Inc. | Pertzye (pancrelipase) Delayed-Release Capsules | 11/17/14 | 12/24/14 | Fulfilled (10/6/16) |
| Braintree Laboratories, Inc. | Suprep Bowel Prep Kit (sodium sulfate, potassium sulfate and magnesium sulfate) Oral Solution | 12/02/14 | 12/15/14 | Fulfilled (6/10/16) |
| VistaPharm, Inc. | oxycodone hydrochloride oral solution | 02/03/15 | 03/31/16 | 1863-1 Fulfilled (7/21/21) |
| Lannett Company, Inc. | Numbrino (cocaine hydrochloride) nasal solution | 07/09/21 | 08/04/21 | |
| Currax Pharmaceuticals LLC | Treximet (sumatriptan and naproxen sodium) tablets | 06/24/21 | 08/05/21 | |
| Exela Pharma Sciences, LLC | Akovaz (ephedrine sulfate injection, USP) | 06/16/21 | 08/02/21 | |
| Sanofi-Aventis US LLC | Allegra-D 12 Hour Allergy & Congestion (fexofenadine hydrochloride 60 mg and pseudoephedrine 120 mg) extended-release tablet | 06/21/21 | 08/04/21 | |
| Merck Sharp & Dohme Corp. | Emend (aprepitant) capsules | 11/06/13 | 11/26/13 | Fulfilled (12/17/15) |
| Merck Sharp & Dohme Corp | Emend (aprepitant) capsules | 11/06/13 | 11/26/13 | Fulfilled (12/17/15) |
| UCB, Inc. | Cimzia (certolizumab pegol) | 11/20/13 | 12/16/13 | |
| ParaPro LLC | Natroba (spinosad) topical suspension, 0.9% | 12/03/13 | 01/17/14 | Fulfilled (12/30/14) |
| Concordia Pharmaceuticals, Inc. | Kapvay (clonidine hydrochloride) 0.1 mg & 0.2 mg extended-release tablets | 01/16/14 | 03/04/14 | Fulfilled (8/16/16) |
| Guerbet LLC | Dotarem (gadoterate meglumine) 0.5 mmol/mL Injection | 01/17/14 | No Response (03/19/14) | Fulfilled (11/5/14) |
| Fresenius Kabi USA, LLC | Smoflipid (lipid injectable emulsion) | 05/24/21 | 06/02/21 | |
| Belcher Pharmatech LLC | esomeprazole strontium capsule | 05/05/21 | 06/21/21 | |
| USWM, LLC | Lucemyra (lofexidine hydrochloride) tablets | 04/19/21 | 06/18/21 | |
| Rhodes Pharmaceuticals, LP |
Aptensio XR (methylphenidate hydrochloride extended-release) capsules
|
07/12/17 | 08/21/17 | Fulfilled (6/14/19) |
| Allergan Sales, LLC |
Viibryd (vilazodone hydrochloride) tablets |
07/06/18 | 08/03/18 | Fulfilled (1/31/20) |
| Tris Pharma, Inc. |
QuilliChew ER (methylphenidate HCl) extended-release chewable tablets
|
04/17/21 | 06/01/21 | |
| Hospira, Inc. |
Precedex (dexmedetomidine hydrochloride) Injection
|
04/01/21 | 04/27/21 | |
| Azurity Pharmaceuticals, Inc. |
Katerzia (amlodipine besylate USP; amlodipine benzoate) suspension |
02/25/21 | 04/09/21 | |
| Alexza Pharmaceuticals, Inc. |
Adasuve (loxapine) inhalation powder for oral inhalation use |
02/19/21 | 04/01/21 | |
| Azurity Pharmaceuticals, Inc. |
Qbrelis (lisinopril) oral solution
|
01/21/21 | 03/05/21 | |
| Hikma Pharmaceuticals USA, Inc. |
Codeine sulfate tablet & oral solution
|
12/22/20 | 02/19/21 | |
| Neos Therapeutics, LP |
Adzenys XR-ODT (amphetamine Extended-Release Orally Disintegrating Tablets) 3.1 mg, 6.3 mg, 9.4 mg, 12.5 mg, 15.7 mg & 18.8 mg
|
12/18/20 | 2/10/21 | |
| Shield Therapeutics (UK) Ltd. | Accrufer (ferric maltol) |
11/24/20 | 1/15/21 | |
| Pacira Pharmaceuticals, Inc. | Exparel (bupivacaine liposome injectable suspension) | 11/04/20 | 11/19/20 | |
| Dentsply Pharmaceutical | Oraqix (lidocaine and prilocaine periodontal gel) 2.5%/2.5% | 06/12/13 | 07/26/13 | User fee was not paid |
| Bayer Healthcare Pharmaceuticals, Inc. | Eovist (gadoxetate disodium) Injection | 06/13/13 | 07/26/13 | Fulfilled (11/25/14) |
| Wyeth Therapeutics, Inc. | Protonix (pantoprazole sodium) Delayed-Release Tablets, 20 mg and 40 mg | 06/14/13 | 07/26/13 | Released & Replaced (7/30/13) |
| Janssen Research & Development, LLC |
Intelence (etravirine) 200 mg, 100 mg, and 25 mg Tablets |
07/15/13 | 08/27/13 | Released & Replaced (6/19/15) |
| Janssen Pharmaceuticals, Inc. | Pancreaze (pancrelipase) Delayed-Release Capsules | 08/06/13 | 09/17/13 | Fulfilled (3/7/14) |
| Tris Pharma, Inc. | QuilliChew ER (methylphenidate hydrochloride) | 10/06/20 | 12/02/20 | |
| Vanda Pharmaceuticals, Inc. | Fanapt (iloperidone) tablets | 10/01/20 | 11/13/20 | |
| Salix Pharmaceuticals, Inc. | Trulance (plecanatide) tablet | 09/17/20 | 10/20/20 | |
| Helsinn Healthcare SA | Aloxi (palonosetron HCl) Injection | 04/11/13 | 05/02/13 | Fulfilled (5/27/14) |
| Helsinn Healthcare SA |
Aloxi (palonosetron HCl) Injection
|
04/11/13 | 05/02/13 | Fulfilled (5/27/14) |
| Incline Therapeutics, Inc. |
Ionsys (fentanyl iontophoretic transdermal system)
|
04/12/13 | 05/09/13 | Released (8/30/19) |
| Vicuron Holdings LLC |
Eraxis (anidulafungin) Powder for Injection
|
04/12/13 | 05/23/13 | Fulfilled (9/22/20) |
| Valeant International Bermuda |
Xerese (acyclovir and hydrocortisone) Cream 5%/1%
|
05/07/13 | 06/21/13 | Fulfilled (1/22/14) |
| Portola Pharmaceuticals, Inc. | Bevyxxa (betrixaban) | 08/14/20 | 10/09/20 | |
| Currax Pharmaceuticals LLC | Onzetra Xsail (sumatriptan nasal powder) 11 mg | 08/12/20 | 09/15/20 | |
| Neos Therapeutics, Inc | Adzenys XR-ODT (amphetamine extended-release orally disintegrating tablets) | 07/28/20 | 08/18/20 | |
| Mylan Ireland Limited | Arixtra (fondaparinux sodium injection) solution | 04/27/20 | 06/16/20 | |
| Rempex Pharmaceuticals, Inc. | Vabomere (meropenem-vaborbactam), Powder for Injection, 1 gram/vial | 05/01/20 | 05/15/20 | |
| Tris Pharma, Inc. | Dyanavel XR (amphetamine) extended-release oral suspension | 03/05/20 | 04/23/20 | |
| Arbor Pharmaceuticals, LLC | Edarbi (azilsartan medoxomil) Tablets, 40 mg & 80 mg |
02/10/20 | 03/26/20 | |
| Teva Pharmaceutical Industries, Ltd. | ArmonAir RespiClick (fluticasone propionate/salmeterol xinafoate inhalation powder |
01/30/20 | 02/19/20 | |
| Teva Pharmaceutical Industries, Ltd. | AirDuo Digihaler/AirDuo RespiClick (fluticasone propionate/salmeterol xinafoate inhalation powder) |
01/30/20 | 02/19/20 | |
| Akebia Therapeutics |
Auryxia (ferric citrate) Tablets |
01/31/20 | 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 (02/08/20) | |
| Cumberland Pharmaceuticals, Inc. | Vibativ (televancin) for Injection, 250 mg & 750 mg | 12/12/19 | 01/15/20 | |
| UCB. Inc. | Cimzia (certolizumab pegol) | 01/31/20 | ||
| AstraZeneca Pharmaceuticals LP | Nexium (esomeprazole magnesium) for delayed release oral suspension | 08/21/19 | 10/03/19 | |
| Supernus Pharmaceuticals | Trokendi XR (topiramate) extended-release capsules | 10/02/19 | 11/8/19 | |
| Ferring Pharmaceuticals, Inc. | Prepopik (citric acid, magnesium oxide, and sodium picosulfate) | 10/04/19 | 11/19/19 | |
| Braintree Laboratories | SUPREP Bowel Prep Kit (sodium sulfate, potassium sulfate and magnesium sulfate) Oral Solution | 07/16/18 | 08/27/18 | Fulfilled(8/5/20) |
| Purdue Pharma | Palladone (hydromorphone hydrochloride extended release) Capsules | 04/10/13 | 05/08/13 (PDF - 591KB)* | Released (1/24/17) |
| Genzyme | Renvela (sevelamer carbonate) Tablets | 04/13/13 | Fulfilled (12/14/16) |
|
| Genzyme | Renvela (sevelamer carbonate) for Oral Suspension | 04/11/13 | 05/24/13 (PDF - 901KB)* | Fulfilled (12/14/16) |
| Genzyme | Hectorol (doxercalciferol capsules) | 04/12/13 |
05/14/13 (PDF - 1.4 MB)* 08/15/13 (PDF - 738K B)* |
|
| Amedra Pharmaceuticals | Twinject/Adrenaclick (epinephrine injection, USP 1:1000) 0.15 mg and 0.3 mg | 05/13/13 | 06/27/13 (PDF - 828 KB)* | Fulfilled (1/30/14) |
| The Medicines Company | Cleviprex (clevidipine) IV emulsion 0.5 mg/mL | 05/14/13 | 06/10/13 (PDF - 775 KB)* | |
| Salix Pharmaceuticals | Apriso (mesalamine) Capsules | 06/10/13 | 007/25/13 (PDF - 75KB)* | |
| Sunovion Pharmaceuticals | Xopenex (levalbuterol HCl) Inhalation Solution | 06/13/13 | 07/24/13 (PDF - 246KB)* | Fulfilled (1/22/15) |
| Pfizer | Protonix I.V. (pantoprazole sodium) for Injection | 06/14/13 | 07/26/13 (PDF - 235KB)* | |
| Pfizer | Protonix I.V. (pantoprazole sodium) for Injection | 06/14/13 | 07/26/13 (PDF - 235 KB)* | |
| Depomed, Inc. | Cambia (diclofenac potassium for oral solution) | 07/03/13 | 08/14/13 (PDF -1 MB) | Released & Replaced (6/20/17) |
| Tris Pharma | Nexiclon (clonidine) Extended Release Oral Suspension | 10/03/13 | No Response (12/02/13) | |
| 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) | 03/06/14 | 04/11/14 (PDF - 820 K B) | |
| Braintree Laboratories | Axid (nizatidine) Oral Solution | 04/02/14 | 05/14/14 (PDF - 472 KB)* | Released (8/8/17) |
| BioAlliance Pharma | Oravig (miconazole) Buccal Tablets, 50 mg | 04/04/14 | 05/09/14 (PDF - 4.8 MB)* | |
| Egalet US, Inc. (formerly Luitpold Pharmaceuticals, Inc.) | Sprix (ketorolac tromethamine) Nasal Spray | 06/12/14 | Supplement (06/18/14) | User fee was not paid |
| Depomed, Inc. | Zipsor (diclofenac potassium) Liquid-Filled Capsules | 01/28/15 | 02/26/15 (PDF - 4.8 MB)* | |
| Acorda Therapeutics, Inc. | Zanaflex (tizanidine) Capsules | 03/19/15 | 04/24/15 (PDF - 2.7 MB) | |
| Meridian Medical Technologies, Inc. | DuoDote (atropine and pralidoxime chloride injection) Auto-Injector | 05/20/15 | 07/01/15 (PDF -7 69 KB)* | |
| Supernus Pharmaceuticals, Inc. | Trokendi XR (topiramate extended release capsules) | 09/29/15 | 11/12/15 (PDF -308 KB)* | |
| Merck Sharpe & Dohme Corp. | Cubicin (daptomycin for injection) 500 mg/vial | 03/03/16 | 04/15/16 (PDF - 1.2 MB) | Fulfilled (3/29/17) |
| Purdue Pharmaceutical Products LP | Dilaudid & Dilaudid HP Injection | 04/21/16 | 06/23/16 (PDF - 88 KB) | |
| Mallinckrodt Inc. | Xartemis XR (oxycodone HCl and acetaminophen) Extended-Release Tablets, 7.5 mg/325 mg | 04/25/16 | 07/15/16 (PDF - 498 KB)* | A deferral extension was requested after the fact & granted 9/1/16 |
| Guerbet LLC | Dotarem (gadoterate meglumine) Injection | 07/07/16 | 08/15/16 (PDF - 1.48 MB)* | |
| Depomed, Inc. | Zipsor (diclofenac potassium) Liquid-Filled Capsules | 07/07/16 | 08/01/16 (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 | 01/12/17 | 03/10/17 (PDF - 681 KB)* | |
| Pfizer | Advil (ibuprofen sodium) tablets, 256 mg | 06/12/17 | 07/21/17 (PDF - 90 KB) | |
| Iroko Pharmaceuticals | Zorvolex (diclofenac) Capsules | 01/25/18 | 03/01/18 (PDF - 363 KB) 03/07/18 (PDF - 359KB) |
|
| Iroko Pharmaceuticals | Tivorbex (indomethacin) Capsules | 06/19/18 | 07/10/18 (PDF - 363 KB) | |
| Vistapharm Inc. | Oxycodone Hydrochloride Oral Solution | 07/09/19 | 08/22/19 (PDF - 86 KB) 11/06/19 (PDF - 714 KB) |