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 Non-Compliance letter and sponsor’s response (with redactions for trade secret or confidential commercial information). These letters have been issued under provisions of the Pediatric Research Equity Act (PREA), which amended the FD&C Act, and are commonly referred to as "PREA Non-Compliance letters."

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=195

Sponsor

Product

Date of Non-Compliance Letter

Date of Sponsor's Response

Comments

Tris Pharma, Inc.

Onyda XR (clonidine hydrochloride) extended-release oral suspension

2/18/26

4/01/26

Teva Pharmaceuticals Inc.

Alvaiz (eltrombopag) tablets

2/06/26

3/06/26

Azurity Pharmaceuticals, Inc.

Eprontia (topiramate) oral solution

2/03/26

3/20/26

Harrow Eye, LLC

IHEEZO (chloroprocaine hydrochloride) ophthalmic gel

2/3/26

No Response

Cosmo Technologies, Ltd.

AEMCOLO (rifamycin) delayed-release tablets

1/23/26

Azurity Pharmaceuticals, Inc.

Eprontia (topiramate) oral solution

11/21/25

01/05/26

Acacia Pharma Ltd

Barhemsys (amisulpride) injection

11/24/25

01/07/26

Shionogi, Inc.

Fetroja (cefiderocol) for injection

10/7/25

10/29/25

A deferral extension was granted on 12/8/25

Exela Pharma Sciences, LLC

Akovaz (ephedrine sulfate) injection

10/03/25

10/21/25

Saptalis Pharmaceuticals, LLC

Likmez (metronidazole) oral suspension

9/30/25

11/07/25

Trevena, Inc.

Olinvyk (oliceridine) injection

9/18/25

10/30/25

Tris Pharma, Inc.

Dyanavel XR (amphetamine) tablets

9/10/25

10/27/25

60 Degrees Pharmaceuticals, Inc

Arakoda (tafenoquine) tablet

9/8/25

No response

A deferral extension was granted on 9/10/25

Genentech, Inc.

Xofluza (baloxavir marboxil) granules for oral suspension and tablets

5/22/24

7/2/24

Fulfilled (12/19/24)

Genentech, Inc.

Xofluza (baloxavir marboxil) tablet and granules for oral suspension

5/22/24

7/2/24

Fulfilled (12/19/24)

Gilead Sciences, Inc.

Harvoni (ledipasvir and sofosbuvir) tablets

5/22/24

6/27/24

Fulfilled (12/19/24)

Gilead Sciences, Inc.

Sovaldi (sofosbuvir) tablets

5/22/24

6/27/24

Fulfilled (12/23/24)

Acer Therapeutics Inc.

Olpruva (sodium phenylbutyrate) powder

11/14/24

12/18/24

Released and Replaced (10/10/25)

Carmel Biosciences, Inc.

Prexxartan (valsartan) oral solution

8/26/25

9/19/25

A deferral extension was granted on 9/9/25

CMP Development LLC

Potassium Phosphates injection

8/16/24

9/27/24

Released (5/13/25)

Athena Bioscience, LLC

QDOLO (tramadol hydrochloride) oral solution

5/22/25

7/3/25

Innocoll Pharmaceuticals Limited

Xaracoll (bupivacaine hydrochloride) implant

9/10/24

No Response

A deferral extension was requested and granted on 9/25/24

Keryx Biopharmaceuticals, Inc.

Auryxia (ferric citrate) tablets

9/10/24

No Response

Nalpropion Pharmaceuticals LLC

Contrave (naltrexone hydrochloride/bupropion hydrochloride) extended-release tablets

10/8/24

10/21/24

Released 10/11/24

Paratek Pharmaceuticals, Inc.

Nuzyra (omadacycline) tablets and Nuzyra (omadacycline) injection

5/6/25

6/17/25

Athena Bioscience, LLC

QDOLO (tramadol hydrochloride) oral solution

4/24/25

6/6/25

Genus Lifesciences Inc.

Oxycodone Hydrochloride capsules and oral solution

6/25/24

8/9/24 8/9/24

A deferral extension was requested and granted on 8/2/24

Acacia Pharma, Ltd.

Byfavo (remimazolam) for injection

4/15/25

5/29/25

Bausch Health Americas, Inc.

DuobrII (halobetasol propionate and tazarotene) lotion

4/07/25

5/15/25

Impel Pharmaceuticals, LLC

Trudhesa (dihydroergotamine mesylate) nasal spray

3/05/25

4/17/25

Hikma Pharmaceuticals USA, Inc.

Phenylephrine Hydrochloride injection

4/03/25

5/14/25

Hong Kong King-Friend Industrial Company Limited

Xenleta (lefamulin) tablets and Xenleta (lefamulin) injection

1/10/25

2/20/25

Heron Therapeutics, Inc.

Cinvanti (aprepitant) injection emulsion

10/2/24

11/14/24

Salix Pharmaceuticals, Inc.

Trulance (plecanatide) tablet

12/6/24

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

Released (3/13/25)

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

Commave Therapeutics SA

Azstarys (serdexmethylphenidate chloride and dexmethylphenidate hydrochloride) capsules

12/01/25

1/30/26

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

5/01/24

6/13/24

Rockwell Medical, Inc.

Triferic AVNU (ferric pyrophosphate citrate) injection

5/06/24

No Response

Rockwell Medical, Inc.

Triferic (ferric pyrophosphate citrate) powder for solution

5/06/24

No Response

Rockwell Medical, Inc.

Triferic (ferric pyrophosphate citrate) for solution

5/03/24

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

4/09/24

5/24/24

Scilex Pharmaceuticals Inc.

Elyxyb (celecoxib) oral solution

4/03/24

5/15/24

Kaleo, Inc.

naloxone hydrochloride injection, auto-injector

4/03/24

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

08/6/18

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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