11/24/2025

Daiichi Sankyo, Inc.

• Untitled Letter (PDF) TURALIO® (pexidartinib) capsules, for oral useNone 9/9/2025

GlaxoSmithKline LLC

• Untitled Letter (PDF)
• Promotional Material (PDF) NDA 215499 APRETUDE (cabotegravir extended-release injectable suspension), for intramuscular useNone 9/30/2025

SK Life Science, Inc.

• Untitled Letter (PDF) Xcopri® (cenobamate tablets) for oral use, CVNone 9/30/2025

PharmaTher Inc.

• Untitled Letter (PDF)
• Promotional Material (PDF) ANDA 217858 KETAMINE HYDROCHLORIDE injection, for intravenous or intramuscular use, CII MA 2None 9/23/2025

AstraZeneca

• Untitled Letter (PDF) FARXIGA® (dapagliflozin) tablets, for oral useNoneClose-Out Letter (PDF) 9/9/2025

Aadi Bioscience

• Untitled Letter (PDF)
• Promotional Material (PDF) FYARRO™ (sirolimus protein-bound particles for injectable suspension) (albuminbound), for intravenous useNoneClose-Out Letter (PDF) 9/23/2025

Novartis Pharmaceuticals Corporation

• Untitled Letter (PDF)
• Promotional Material (PDF) FABHALTA® (iptacopan) capsules, for oral useNone 9/9/2025

Altor BioScience, LLC, (an indirect wholly-owned subsidiary of ImmunityBio, Inc.)

• Untitled Letter (PDF)
• Promotional Material (PDF) ANKTIVA® (nogapendekin alfa inbakicept-pmln) solution, for intravesical useNone 9/9/2025

Takeda Pharmaceuticals America, Inc.

• Untitled Letter (PDF)
• Promotional Material (PDF) ICLUSIG® (ponatinib) tablets, for oral useNone 9/9/2025

Amgen Inc.

• Untitled Letter (PDF) IMDELLTRA™ (tarlatamab-dlle) for injection, for intravenous useNone 9/9/2025

Evolus, Inc.

• Untitled Letter (PDF)
• Promotional Material (PDF) JEUVEAU® (prabotulinumtoxinA-xvfs) for injection, for intramuscular useNoneClose-Out Letter (PDF) 9/9/2025

Incyte Corporation

• Untitled Letter (PDF)
• Promotional Material (PDF) PEMAZYRE® (pemigatinib) tablets, for oral useNoneClose-Out Letter (PDF) 9/9/2025

Pinnacle Biologics, Inc.

• Untitled Letter (PDF)
• Promotional Material (PDF) PHOTOFRIN® (porfimer sodium) for injection, for intravenous useNoneClose-Out Letter (PDF) 9/9/2025

Pinnacle Biologics, Inc.

• Untitled Letter (PDF)
• Promotional Material (PDF) PHOTOFRIN® (porfimer sodium) for injection, for intravenous useNoneClose-Out Letter (PDF) 9/9/2025

UCB, Inc.

• Untitled Letter (PDF)
• Promotional Material (PDF) RYSTIGGO® (rozanolixizumab-noli) injection, for subcutaneous useNone 9/9/2025

AbbVie, Inc.

• Untitled Letter (PDF)
• Promotional Material (PDF) SKYRIZI® (risankizumab-rzaa) injection, for subcutaneous or intravenous useNone 9/9/2025

Ipsen Biopharmaceuticals, Inc.

• Untitled Letter (PDF)
• Promotional Material (PDF) TAZVERIK® (tazemetostat) tablets, for oral useNoneClose-Out Letter (PDF) 9/9/2025

Alnylam Pharmaceuticals, Inc.

• Untitled Letter (PDF) AMVUTTRA® (vutrisiran) injection, for subcutaneous useNoneClose-Out Letter (PDF) 9/9/2025

BridgeBio Pharma, Inc.

• Untitled Letter (PDF)
• Promotional Material (PDF) ATTRUBY® (acoramidis) tabletsNoneClose-Out Letter (PDF) 9/9/2025

Teva Neuroscience, Inc.

• Untitled Letter (PDF) AUSTEDO® XR (deutetrabenazine) extended-release tablets, for oral useNone 9/9/2025

Teva Neuroscience, Inc.

• Untitled Letter (PDF) AUSTEDO® XR (deutetrabenazine) extended-release tablets, for oral useNone 9/9/2025

Axsome Therapeutics, Inc.

• Untitled Letter (PDF)
• Promotional Material (PDF) AUVELITY® (dextromethorphan hydrobromide and bupropion hydrochloride) extended-release tablets, for oral useNone 9/9/2025

UCB, Inc.

• Untitled Letter (PDF)
• Promotional Material (PDF) BIMZELX® (bimekizumab-bkzx) injection, for subcutaneous useNone 9/9/2025

UCB, Inc.

• Untitled Letter (PDF)
• Promotional Material (PDF) BIMZELX® (bimekizumab-bkzx) injection, for subcutaneous useNone 9/9/2025

UCB, Inc.

• Untitled Letter (PDF)
• Promotional Material (PDF) BIMZELX® (bimekizumab-bkzx) injection, for subcutaneous useNone 9/9/2025

AstraZeneca Pharmaceuticals LP

• Untitled Letter (PDF)
• Promotional Material (PDF) CALQUENCE® (acalabrutinib) capsules, for oral useNone 9/9/2025

Bristol Myers Squibb

• Untitled Letter (PDF)
• Promotional Material (PDF) CAMZYOS® (mavacamten) capsules for oral useNone 9/9/2025

Nalpropion Pharmaceuticals, LLC

• Untitled Letter (PDF)
• Promotional Material (PDF) CONTRAVE (naltrexone hydrochloride and bupropion hydrochloride) extended release tablets, for oral useNone 9/9/2025

Azurity Pharmaceuticals, Inc.

• Untitled Letter (PDF)
• Promotional Material (PDF) DANZITEN (nilotinib) tablets, for oral useNone 9/9/2025

AstraZeneca Pharmaceuticals LP

• Untitled Letter (PDF)
• Promotional Material (PDF) FASENRA® (benralizumab) injection, for subcutaneous useNone 9/9/2025

AstraZeneca Pharmaceuticals LP

• Untitled Letter (PDF) FASENRA® (benralizumab) injection, for subcutaneous useNone 9/9/2025

AstraZeneca Pharmaceuticals LP

• Untitled Letter (PDF) FASENRA® (benralizumab) injection, for subcutaneous useNone 9/9/2025

Takeda Pharmaceuticals USA, Inc.

• Untitled Letter (PDF)
• Promotional Material (PDF) FRUZAQLA® (fruquintinib) capsules, for oral useNoneClose-Out Letter (PDF) 9/9/2025

Takeda Pharmaceuticals USA, Inc.

• Untitled Letter (PDF)
• Promotional Material (PDF) FRUZAQLA® (fruquintinib) capsules, for oral useNone 9/9/2025

Neurocrine Biosciences, Inc

• Untitled Letter (PDF)
• Promotional Material (PDF) INGREZZA® (valbenazine) capsules, for oral useNone 9/9/2025

Novartis Pharmaceuticals Corporation

• Untitled Letter (PDF)
• Promotional Material (PDF) KESIMPTA® (ofatumumab) injection, for subcutaneous useNone 9/9/2025

Boehringer Ingelheim Pharmaceuticals, Inc.

• Untitled Letter (PDF) JARDIANCE® (empagliflozin tablets), for oral useNone 9/9/2025

Boehringer Ingelheim Pharmaceuticals, Inc.

• Untitled Letter (PDF) JARDIANCE® (empagliflozin tablets), for oral useNone 9/9/2025

Boehringer Ingelheim Pharmaceuticals, Inc.

• Untitled Letter (PDF) JARDIANCE® (empagliflozin tablets), for oral useNone 9/9/2025

Bausch Health Companies Inc.

• Untitled Letter (PDF)
• Promotional Material (PDF) JUBLIA® (efinaconazole) topical solution, 10% for topical useNoneClose-Out Letter (PDF) 9/9/2025

Novartis Pharmaceuticals Corporation

• Untitled Letter (PDF)
• Promotional Material (PDF) KISQALI® (ribociclib) tablets, for oral useNone 9/9/2025

AbbVie, Inc.

• Untitled Letter (PDF)
• Promotional Material (PDF) LINZESS® (linaclotide) capsules, for oral useNone 9/9/2025

ARS Pharmaceutical Operations, Inc.

• Untitled Letter (PDF) NEFFY® (epinephrine nasal spray)None 9/9/2025

Galderma Laboratories, L.P.

• Untitled Letter (PDF) NEMLUVIO® (nemolizumab-ilto) for injection, for subcutaneous useNone 9/9/2025

Bristol-Myers Squibb

• Untitled Letter (PDF) OPDIVO QVANTIG™ (nivolumab and hyaluronidase-nvhy) injection, for subcutaneous useNone 9/9/2025

Bristol-Myers Squibb

• Untitled Letter (PDF)

OPDIVO® (nivolumab) injection, for intravenous use

YERVOY® (ipilimumab) injection, for intravenous use

None 9/9/2025

Supernus Pharmaceuticals, Inc.

• Untitled Letter (PDF)
• Promotional Material (PDF) QELBREE® (viloxazine extended-release capsules), for oral useNone 9/9/2025

Supernus Pharmaceuticals, Inc.

• Untitled Letter (PDF)
• Promotional Material (PDF) QELBREE® (viloxazine extended-release capsules), for oral useNone 9/9/2025

AbbVie, Inc.

• Untitled Letter (PDF)
• Promotional Material (PDF) QULIPTA® (atogepant) tablets, for oral useNone 9/9/2025

Novartis Pharmaceuticals Corporation

• Untitled Letter (PDF)
• Promotional Material (PDF) PLUVICTO® (lutetium Lu 177 vipivotide tetraxetan) injection, for intravenous useNone 9/9/2025

AstraZeneca Pharmaceuticals LP

• Untitled Letter (PDF) TRUQAP® (capivasertib) tablets, for oral useNone 9/9/2025

Sanofi

• Untitled Letter (PDF) TZIELD® (teplizumab-mzwv) injection, for intravenous useNoneClose-out Letter (PDF) 9/9/2025

Pfizer, Inc.

• Untitled Letter (PDF)
• Promotional Material (PDF) VELSIPITY™ (etrasimod) tablets, for oral useNone 9/9/2025

Phathom Pharmaceuticals, Inc.

• Untitled Letter (PDF) VOQUEZNA (vonoprazan) tablets, for oral useNone 9/9/2025

Phathom Pharmaceuticals, Inc.

• Untitled Letter (PDF) VOQUEZNA (vonoprazan) tablets, for oral useNone 9/9/2025

Phathom Pharmaceuticals, Inc.

• Untitled Letter (PDF) VOQUEZNA (vonoprazan) tablets, for oral useNone 9/9/2025

Alexion Pharmaceuticals, Inc.

• Untitled Letter (PDF) ULTOMIRIS® (ravulizumab-cwvz) injection, for intravenous useNone 4/28/2025

Mayne Pharma LLC

• Untitled Letter (PDF)
• Promotional Material (PDF) NEXTSTELLIS (drospirenone and estetrol tablets), for oral useNoneClose-Out Letter (PDF) 3/21/2025

Taiho Oncology, Inc.

• Untitled Letter (PDF)
• Promotional Material (PDF) NDA 214801, LYTGOBI (futibatinib) tablets, for oral useNoneClose-Out Letter (PDF) 2/3/2025

Edenbridge DBA Dexcel

• Untitled Letter (PDF)
• Promotional Material (PDF) NDA 211379, HEMADY (dexamethasone tablets), for oral useNoneClose-Out Letter (PDF) 10/31/2024

Merz Pharmaceuticals GmbH

• Untitled Letter (PDF)
• Promotional Material (MP4 | Duration: 1min 14sec ) BLA 125360 XEOMIN (incobotulinumtoxinA) for injection, for intramuscular or intraglandular useNoneClose-Out Letter (PDF) 8/29/2024

AbbVie, Inc.

• Untitled Letter (PDF)
• Promotional Material (PDF) NDA 211765, UBRELVY (ubrogepant) tablets, for oral useNoneClose-Out Letter (PDF) 8/1/2024

Mirati Therapeutics Inc., a Bristol Myers Squibb Co.

• Untitled Letter (PDF)
• Promotional Material (PDF) NDA 216340, KRAZATI™ (adagrasib) tablets, for oral useNoneClose-Out Letter (PDF) 7/17/2024

Kaleo, Inc.

• Untitled Letter (PDF)
• Promotional Material (PDF)
• Promotional Material (MP4 | Duration: 40sec) NDA 201739, AUVI-Q (epinephrine injection, USP), for intramuscular or subcutaneous useNoneClose-Out Letter (PDF) 1/18/2024

Novartis Pharmaceuticals Corporation

• Untitled Letter (PDF)
• Promotional Material (PDF) NDA 209092 KISQALI (ribociclib) tablets, for oral useNoneClose-Out Letter (PDF) 10/31/2023

Otsuka Pharmaceutical Development and Commercialization, Inc

• Untitled Letter (PDF)
• Promotional Material (PDF)
• Promotional Material (PDF) NDA 205422 REXULTI (brexpiprazole) tablets, for oral useNoneClose-Out Letter (PDF) 10/31/2023

Evofem Biosciences

• Untitled Letter (PDF)
• Promotional Material (PDF) NDA 208352 PHEXXI (lactic acid, citric acid, and potassium bitartrate) vaginal gelNoneClose-Out Letter (PDF) 6/07/2023

Xeris Pharmaceuticals, Inc.

• Untitled Letter (PDF)
• Promotional Material (PDF) NDA 214133 RECORLEV (levoketoconazole) tablets, oralNoneClose-Out Letter (PDF) 8/11/2023

Exeltis USA Inc.

• Untitled Letter (PDF)
• Promotional Material (PDF) NDA 211367 SLYND (drospirenone) tablets, oralNoneClose-Out Letter (PDF) 01/19/2022

Eli Lilly & Company

• Untitled Letter (PDF)
• Promotional Material (PDF) BLA 125469 TRULICITY® (dulaglutide) injection, for subcutaneous useNoneClose-Out Letter (PDF) 3/31/2022

Bausch Health Companies Inc

• Untitled Letter (PDF)
• Promotional Material (PDF)
• Promotional Material (PDF) NDA 209354 DUOBRII (halobetasol propionate and tazarotene) lotion, for topical useNoneClose-Out Letter (PDF) 6/02/2022

Althera Pharmaceuticals

• Untitled Letter (PDF)
• Promotional Material (PDF) NDA 213072 ROSZET (rosuvastatin ezetimibe) tables, for oral useNoneClose-Out Letter (PDF) 12/13/2021

Emgality

• Untitled Letter (PDF) BLA 761063 EMGALITY (galcanezumab-gnlm) injection, for subcutaneous useResponse Letter (PDF)Close-Out Letter (PDF) 8/09/2021

Alkindi Sprinkle

• Untitled Letter (PDF)
• Promotional Material (PDF) NDA 213876 ALKINDI® SPRINKLE (hydrocortisone) oral granulesNoneClose-Out Letter (PDF) 7/07/2021

Amgen

• Untitled Letter (PDF)
• Promotional Material (PDF) BLA 125031 NEULASTA® (pegfilgrastim) injection, for subcutaneous useNoneClose-Out Letter (PDF) 3/08/2021

Biohaven Pharmaceuticals

• Untitled Letter (PDF) NDA 212728 NURTEC ODT (rimegepant) orally disintegrating tablets, for sublingual or oral useNoneClose-Out Letter (PDF) 11/24/2020

Azurity Pharmaceuticals Inc.

• Untitled Letter (PDF)
• Promotional Material (PDF) NDA 208400 XATMEP® (methotrexate) oral solutionNoneNone 8/14/2020

Xeris Pharmaceuticals, Inc.

• Untitled Letter (PDF) NDA 212097 GVOKETM (glucagon) injection, for subcutaneous use NoneNone 11/18/2019

Rockwell Medical, Inc

• Untitled Letter (PDF)
• Promotional Material (PDF) NDA 206317; NDA 208551 TRIFERIC (ferric pyrophosphate citrate) solution and TRIFERIC® (ferric pyrophosphate citrate) powder packet for addition to bicarbonate concentrationNoneNone 11/01/2019

Nascent Biotech, Inc.

• Untitled Letter (PDF)
• Promotional Material (PDF) PritumumabNoneNone 9/24/2019

Kowa Pharmaceuticals, Inc.

• Untitled Letter (PDF) NDA 022363 Livalo (pitavastatin) tablet, for oral useNoneNone 7/25/2019

CooperSurgical, Inc.

• Untitled Letter (PDF)
• Promotional Material (PDF) NDA 018680 ParaGard T380A Intrauterine Copper ContraceptiveNoneNone 6/14/2019

Aclaris Therapeutics, Inc.

• Untitled Letter (PDF)
• Promotional Material (PDF) NDA 209305 ESKATA (hydrogen peroxide) topical solutionNoneNone 5/22/2019

VIVUS, Inc.

• Untitled Letter (PDF)
• Promotional Material (PDF) NDA 022580 QSYMIA (phentermine and topiramate extended-release) capsules, for oral use, CIVNoneNone 2/15/2019

Phoenix Molecular Imaging Center

• Untitled Letter (PDF)
• Promotional Material (PDF) Sodium Acetate (C-11)NoneNone 10/11/2018

Eisai Inc.

• Untitled Letter (PDF)

• NDA 202834; 208277

• Fycompa (perampanel) oral suspension, CIII

• Fycompa(perampanel) tablets, for oral use, CIII NoneNone 8/16/2018

ASCEND Therapeutics US, LLC

• Untitled Letter (PDF)
• Promotional Material (PDF) NDA 021166 EstroGel 0.06% (estradiol gel) for topical useNoneNone 6/28/2018

Arog Pharmaceuticals, Inc.

• Untitled Letter (PDF)
• Promotional Material (PDF) Crenolanib besylateNoneNone 6/19/2018

Pfizer Inc.

• Untitled Letter (PDF) NDA 020472 ESTRING® (estradiol vaginal ring)NoneNone 2/09/2018

Collegium Pharmaceuticals, Inc.

• Untitled Letter (PDF)
• Promotional Material (PDF) NDA 208090 Xtampza ER (oxycodone) extended-release capsules, for oral useNoneNone 12/28/2017

University of California Los Angeles (UCLA)

• Untitled Letter (PDF)
• Promotional Material (PDF) Gallium 68 (68GA-PSMA) (Prostate Cancer Imaging webpage and brochure)NoneNone 5/18/2017

Orexigen Therapeutics, Inc.

• Untitled Letter
• Promotional Material (PDF) NDA 200063 CONTRAVE (naltrexone HCl and bupropion HCl) Extended-Release TabletsNoneNone