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  1. Warning Letters and Notice of Violation Letters to Pharmaceutical Companies

Untitled Letters

These letters are supplied by the CDER Freedom of Information Office and only cover Office of Prescription Drug Promotion's untitled letters. The agency may have redacted or edited some of the letters to remove confidential information.

1997-2016 Compliance Actions are archived. To view them, please see the FDA Archive.

To view OPDP Warning Letters, please see Warning Letters.

Office of Prescription Drug Promotion Untitled Letters and Corresponding Promotional Communications

Issued Date Company / Individual Product / Issue Response Letter Closeout Letter
1/18/2024

Novartis Pharmaceuticals Corporation

NDA 209092
KISQALI (ribociclib) tablets, for oral use
None  
10/31/2023

Otsuka Pharmaceutical Development and Commercialization, Inc

NDA 205422 REXULTI (brexpiprazole) tablets, for oral use None Close-Out Letter (PDF)
10/31/2023

Evofem Biosciences

NDA 208352 PHEXXI (lactic acid, citric acid, and potassium bitartrate) vaginal gel None Close-Out Letter (PDF)
6/07/2023

Xeris Pharmaceuticals, Inc.

NDA 214133 RECORLEV (levoketoconazole) tablets, oral None

Close-Out Letter (PDF)

8/11/2023

Exeltis USA Inc.

NDA 211367 SLYND (drospirenone) tablets, oral None

Close-Out Letter (PDF)

01/19/2022

Eli Lilly & Company

BLA 125469 TRULICITY® (dulaglutide) injection, for subcutaneous use

None Close-Out Letter (PDF)
3/31/2022

Bausch Health Companies Inc 

NDA 209354 DUOBRII (halobetasol propionate and tazarotene) lotion, for topical use None

Close-Out Letter (PDF)

6/02/2022

Althera Pharmaceuticals

NDA 213072 ROSZET (rosuvastatin ezetimibe) tables, for oral use None

Close-Out Letter (PDF)

12/13/2021

Emgality

BLA 761063 EMGALITY (galcanezumab-gnlm) injection, for subcutaneous use

Response Letter (PDF)

Close-Out Letter (PDF)

8/09/2021

Alkindi Sprinkle

NDA 213876 ALKINDI® SPRINKLE (hydrocortisone) oral granules

None

Close-Out Letter (PDF)

7/07/2021

Amgen

BLA 125031 NEULASTA® (pegfilgrastim) injection, for subcutaneous use

None

Close-Out Letter (PDF)

3/08/2021

Biohaven Pharmaceuticals

NDA 212728 NURTEC ODT (rimegepant) orally disintegrating tablets, for sublingual or oral use

None

Close-Out Letter (PDF)

11/24/2020

Azurity Pharmaceuticals Inc.

NDA 208400 XATMEP® (methotrexate) oral solution None None
8/14/2020

Xeris Pharmaceuticals, Inc.

NDA 212097 GVOKETM (glucagon) injection, for subcutaneous use  None None
11/18/2019

Rockwell Medical, Inc

NDA 206317; NDA 208551 TRIFERIC (ferric pyrophosphate citrate) solution and TRIFERIC® (ferric pyrophosphate citrate) powder packet for addition to bicarbonate concentration None None
11/01/2019

Nascent Biotech, Inc.

Pritumumab None None
9/24/2019

Kowa Pharmaceuticals, Inc.

NDA 022363 Livalo (pitavastatin) tablet, for oral use None None
7/25/2019

CooperSurgical, Inc.

NDA 018680 ParaGard T380A Intrauterine Copper Contraceptive None None
6/14/2019

Aclaris Therapeutics, Inc.

NDA 209305 ESKATA (hydrogen peroxide) topical solution None None
5/22/2019

VIVUS, Inc.

NDA 022580 QSYMIA (phentermine and topiramate extended-release) capsules, for oral use, CIV

None None
2/15/2019

Phoenix Molecular Imaging Center

Sodium Acetate (C-11) None None
10/11/2018

Eisai Inc.

  • NDA 202834; 208277
  • Fycompa (perampanel) oral suspension, CIII
  • Fycompa(perampanel) tablets, for oral use, CIII
None None
8/16/2018

ASCEND Therapeutics US, LLC

NDA 021166 EstroGel 0.06% (estradiol gel) for topical use

None None
6/28/2018

Arog Pharmaceuticals, Inc.

Crenolanib besylate

None None
6/19/2018

Pfizer Inc.

NDA 020472 ESTRING® (estradiol vaginal ring)

None None
 2/09/2018

Collegium Pharmaceuticals, Inc.

NDA 208090 Xtampza ER (oxycodone) extended-release capsules, for oral use

None None
12/28/2017

University of California Los Angeles (UCLA)

Gallium 68 (68GA-PSMA) (Prostate Cancer Imaging webpage and brochure)

None None
5/18/2017

Orexigen Therapeutics, Inc.

NDA 200063 CONTRAVE (naltrexone HCl and bupropion HCl) Extended-Release Tablets

None None
 
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