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 |
|---|---|---|---|---|
| 10/31/2024 | Merz Pharmaceuticals GmbH
| BLA 125360 XEOMIN (incobotulinumtoxinA) for injection, for intramuscular or intraglandular use | None | None |
| 8/29/2024 | AbbVie, Inc.
| NDA 211765, UBRELVY (ubrogepant) tablets, for oral use | None | Close-Out Letter (PDF) |
| 8/1/2024 | Mirati Therapeutics Inc., a Bristol Myers Squibb Co.
| NDA 216340, KRAZATI™ (adagrasib) tablets, for oral use | None | Close-Out Letter (PDF) |
| 7/17/2024 | Kaleo, Inc.
| NDA 201739, AUVI-Q (epinephrine injection, USP), for intramuscular or subcutaneous use | None | Close-Out Letter (PDF) |
| 1/18/2024 | Novartis Pharmaceuticals Corporation
| NDA 209092 KISQALI (ribociclib) tablets, for oral use | None | Close-Out Letter (PDF) |
| 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.
|
| 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 |