Office of Prescription Drug Promotion Untitled Letters

8/29/2024

AbbVie, Inc.

UBRELVY (ubrogepant) tablets, for oral use None None 8/1/2024

Mirati Therapeutics Inc., a Bristol Myers Squibb Co.

NDA 216340, KRAZATI™ (adagrasib) tablets, for oral use None None 7/17/2024

Kaleo, Inc.

NDA 201739, AUVI-Q (epinephrine injection, USP), for intramuscular or subcutaneous use None None 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.

• 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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