Non-Compliance Letters under 505B(d)(1)

Heron Therapeutics, Inc. Cinvanti (aprepitant) injection emulsion 10/02/24 11/14/24   Salix Pharmaceuticals, Inc. Trulance (plecanatide) tablet 12/06/24 12/23/24 A deferral extension was requested and granted on 12/27/24 Keryx Biopharmaceuticals, Inc. Auryxia (ferric citrate) tablets 9/20/24 11/1/24   Nextwave Pharmaceuticals, Inc. QuilliChew ER (methylphenidate hydrochloride) extended-release chewable tablet 6/13/24 7/26/24   Innocoll Pharmaceuticals Limited Xaracoll (bupivacaine hydrochloride) implant 5/28/24 7/15/24   Commave Therapeutics SA Azstarys (serdexmethylphenidate chloride and dexmethylphenidate hydrochloride) capsules 5/17/24 6/28/24 A deferral extension was requested, after the non-compliance letter was issued, and granted on 8/9/24 Heron Therapeutics, Inc. Zynrelef (bupivacaine and meloxicam) extended-release solution 5/16/24 6/27/24   Trevena, Inc. Olinvyk (oliceridine) injection 5/10/24 6/10/24   US WorldMeds (USVM), LLC Lucemyra (lofexidine hydrochloride) tablets 4/24/24 6/7/24   Acacia Pharma Ltd Byfavo (remimazolam) for injection 5/1/24 6/13/24   Rockwell Medical, Inc. Triferic AVNU (ferric pyrophosphate citrate) injection 5/6/24 No Response   Rockwell Medical, Inc. Triferic (ferric pyrophosphate citrate) powder for solution 5/6/24 No Response   Rockwell Medical, Inc. Triferic (ferric pyrophosphate citrate) for solution 5/3/24 No Response   Ironshore Pharmaceuticals & Development, Inc. Jornay PM (methylphenidate hydrochloride) extended-release capsules 4/23/24 5/29/24   Upsher-Smith Laboratories, LLC Qudexy XR (topiramate) extended-release capsules 4/22/24 5/28/24   Zyla Life Sciences US, Inc. Sprix (ketorolac tromethamine) nasal spray 4/16/24 No response   Benuvia Operations, LLC Syndros (dronabinol) oral solution 4/12/24 No response   Athena Bioscience, LLC Qdolo (tramadol hydrochloride) oral solution 4/25/24 6/7/24   Aquestive Therapeutics Inc. Zuplenz (ondansetron) oral soluble film 4/23/24 6/7/24   Incyte Corp. Opzelura (ruxolitinib) cream 4/23/24 6/7/24   Azurity Pharmaceuticals Inc. Edarbi (azilsartan medoxomil) tablets 4/9/24 5/24/24   Scilex Pharmaceuticals Inc. Elyxyb (celecoxib) oral solution 4/3/24 5/15/24   Kaleo, Inc. naloxone hydrochloride injection, auto-injector 4/3/24 4/15/24   Neos Therapeutics Brand, LLC Cotempla XR-ODT (methylphenidate) extended-release orally disintegrating tablets 3/27/24 5/29/24   Noden Pharma Designated Activity Company Goprelto (cocaine hydrochloride) solution 3/28/24 4/19/24   Primus Pharmaceuticals Inc Impoyz (clobetasol propionate) cream 2/21/24 No response   Primus Pharmaceuticals Inc Impoyz (clobetasol propionate) cream 7/26/23 8/23/2023   Hikma Pharmaceuticals USA, Inc. morphine sulfate oral solution and tablets 6/14/23 9/14/23   Chattem, Inc. Allegra-D 12 Hour Allergy and Congestion (fexofenadine hydrochloride; pseudoephedrine hydrochloride) extended release tablets 7/21/23 No response   Ardelyx Inc Ibsrela (tenapanor) tablets 4/19/23 5/10/23   Nalpropion Pharmaceuticals LLC Contrave (naltrexone hydrochloride/bupropion hydrochloride) extended-release tablets 4/12/23 5/10/23   Hikma Pharmaceuticals USA, Inc Phenylephrine hydrochloride injection 5/31/23 No Response   Salix Pharmaceuticals Inc. Trulance (plecanatide) tablets 3/31/23 5/10/23   Esperion Therapeutics, Inc.  Nexletol (bempedoic acid) tablets and Nexlizet (bempedoic acid and ezetimibe) tablets 11/21/22 12/26/22   Mylan Ireland LTD Arixtra (fondaparinux sodium injection) solution 2/28/23 4/13/23   Helsinn Healthcare SA Akynzeo (netupitant and palonosetron) capsules 11/17/22 12/21/22 Released & Replaced (2/16/23) 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 Released (10/6/23) 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 – Fulfilled (12/17/15) UCB, Inc. Cimzia (certolizumab pegol) 11/20/13 –   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 nzetra 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) 12/20/19 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 Released (1/24/17) Genzyme Renvela (sevelamer carbonate) Tablets 04/13/13 05/24/13 Fulfilled (12/14/16) Genzyme Renvela (sevelamer carbonate) for Oral Suspension 04/11/13 05/24/13 Fulfilled (12/14/16) Genzyme Hectorol (doxercalciferol capsules) 04/12/13 05/14/13
08/15/13   Amedra Pharmaceuticals Twinject/Adrenaclick (epinephrine injection, USP 1:1000) 0.15 mg and 0.3 mg 05/13/13 06/27/13 Fulfilled (1/30/14) The Medicines Company Cleviprex (clevidipine) IV emulsion 0.5 mg/mL 05/14/13 06/10/13   Salix Pharmaceuticals Apriso (mesalamine) Capsules 06/10/13 007/25/13   Sunovion Pharmaceuticals Xopenex (levalbuterol HCl) Inhalation Solution 06/13/13 07/24/13 Fulfilled (1/22/15) Pfizer Protonix I.V. (pantoprazole sodium) for Injection 06/14/13 07/26/13   Pfizer Protonix I.V. (pantoprazole sodium) for Injection 06/14/13 07/26/13   Depomed, Inc. Cambia (diclofenac potassium for oral solution) 07/03/13 08/14/13 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   Braintree Laboratories Axid (nizatidine) Oral Solution 04/02/14 05/14/14 Released (8/8/17) BioAlliance Pharma Oravig (miconazole) Buccal Tablets, 50 mg 04/04/14 05/09/14   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)  

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