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Home › Decisions › CRL letters

FDA Complete Response Letters: 444 released CRLs

Updated ·next FDA decision on the calendar
The FDA releases Complete Response Letters under its CRL transparency program. This page lists all 444 released letters, newest first, each linking the original PDF on FDA's servers. 159 letters are from 2024 or later; the archive reaches back to 2002. Where a letter matches a decision this site tracked, the decision page (with the run-up chart and outcome) is linked beside it. This page states counts, never approval rates; the FAQ below explains why a rate from this data would mislead.

2026 · 32 letters

DateCompanyApplicationLetterOn this site
Aug 7, 2026ITM Solucin GmbHNDA 218705letter (PDF)n/a
Jul 21, 2026Apiject Systems Corp.NDA 219107letter (PDF)n/a
Jul 9, 2026Jiangsu Hengrui Pharmaceuticals Co., Ltd.BLA 761308letter (PDF)n/a
Jul 9, 2026Elevar Therapeutics Inc.NDA 216586letter (PDF)n/a
Jul 2, 2026Ascelia Pharma ABNDA 220544letter (PDF)n/a
Jun 29, 2026Ipsen Biopharm Ltd.BLA 761311letter (PDF)n/a
Jun 29, 2026Unicycive Therapeutics Inc.NDA 218607letter (PDF)n/a
Jun 26, 2026Evergreen Theragnostics, Inc.NDA 216900letter (PDF)n/a
Jun 26, 2026Swedish Orphan Biovitrum AB (publ)BLA 761438letter (PDF)n/a
Jun 23, 2026Tanvex BioPharma USA, Inc.BLA 761266letter (PDF)n/a
Jun 20, 2026Achieve Life Sciences, Inc.NDA 218995letter (PDF)n/a
Jun 15, 2026Tris Pharma, Inc.NDA 220138letter (PDF)n/a
Jun 10, 2026Bridge Regulatory Affairs, LLCNDA 218600letter (PDF)n/a
Jun 4, 2026Xspray Pharma ABNDA 217644letter (PDF)n/a
May 29, 2026Cingulate Therapeutics, LLCNDA 220283letter (PDF)n/a
May 15, 2026Ocuvex Therapeutics, Inc.NDA 217363letter (PDF)n/a
Apr 23, 2026Grace Therapeutics U.S., Inc.NDA 220304letter (PDF)n/a
Apr 22, 2026AbbVie Inc.BLA 761459letter (PDF)decision page
Apr 13, 2026Eagle Pharmaceuticals, Inc.NDA 220045letter (PDF)n/a
Apr 10, 2026Replimune, Inc.BL 125827letter (PDF)decision page
Apr 10, 2026Telix Pharmaceuticals (US) Inc.BLA 761401letter (PDF)n/a
Mar 16, 2026Aldeyra Therapeutics, Inc.NDA 216442letter (PDF)n/a
Mar 5, 2026Rosemont Pharmaceuticals Holdings, Inc.NDA 220140letter (PDF)n/a
Feb 27, 2026Fresenius Kabi USA, LLCNDA 214610letter (PDF)n/a
Feb 27, 2026Ferring Pharmaceuticals Inc.BLA 761253letter (PDF)n/a
Feb 27, 2026Fresenius Kabi USA, LLCNDA 215818letter (PDF)n/a
Feb 26, 2026Amphastar Pharmaceuticals, Inc.BLA 761403letter (PDF)n/a
Feb 13, 2026Disc Medicine, Inc.NDA 220707letter (PDF)decision page
Feb 7, 2026REGENXBIO, Inc.BL 125840letter (PDF)decision page
Jan 30, 2026Aquestive Therapeutics Inc.NDA 219870letter (PDF)n/a
Jan 28, 2026Corcept TherapeuticsNDA 219398letter (PDF)n/a
Jan 9, 2026Pierre Fabre Pharmaceuticals Inc.BL 125745letter (PDF)n/a

2025 · 58 letters

DateCompanyApplicationLetterOn this site
Dec 30, 2025Dr. Reddy’s Laboratories, Inc.BLA 761471letter (PDF)n/a
Dec 30, 2025Outlook Therapeutics, Inc.BLA 761320letter (PDF)decision page
Dec 23, 2025Genzyme CorporationNDA 219624letter (PDF)n/a
Dec 22, 2025MedicaSafe, Inc.NDA 220184letter (PDF)n/a
Dec 16, 2025GlaxoSmithKline LLCBLA 761458/Original 2, BLA 7letter (PDF)n/a
Dec 12, 2025LIB Therapeutics, Inc.BLA 761427/Original 2, BLA 7letter (PDF)n/a
Dec 9, 2025Sandoz Inc.BLA 761271letter (PDF)n/a
Nov 26, 2025Alvotech USA Inc.BLA 761461letter (PDF)n/a
Nov 24, 2025Alvotech USA Inc.BLA 761435letter (PDF)n/a
Nov 6, 2025Accord Healthcare Inc.NDA 216987letter (PDF)n/a
Nov 4, 2025Biohaven Therapeutics, Ltd.NDA 210862letter (PDF)n/a
Oct 31, 2025Alvotech USA Inc.BLA 761462letter (PDF)n/a
Oct 23, 2025Shanghai Auzone Biological Technology Co., LNDA 219846letter (PDF)n/a
Oct 23, 2025GlaxoSmithKline LLCBLA 761440/Original 2, BLA 7letter (PDF)n/a
Oct 22, 2025SYDNEXIS Inc.NDA 219694letter (PDF)n/a
Oct 21, 2025NeuroDerm, Ltd.NDA 218317letter (PDF)n/a
Oct 16, 2025Dr. Reddy’s Laboratories SABLA 761376letter (PDF)n/a
Oct 10, 2025AstraZeneca Pharmaceuticals LPBLA 761451letter (PDF)n/a
Oct 7, 2025Xspray Pharma ABNDA 216195letter (PDF)n/a
Sep 30, 2025Sentynl Therapeutics, Inc.NDA 211241letter (PDF)n/a
Sep 22, 2025Scholar Rock, Inc.BLA 761463letter (PDF)n/a
Sep 22, 2025Biogen, Inc.NDA 209531/S-016letter (PDF)n/a
Aug 27, 2025Saol International Development LimitedNDA 218679letter (PDF)n/a
Aug 27, 2025Outlook Therapeutics, Inc.BLA 761320letter (PDF)decision page
Aug 18, 2025PTC Therapeutics, Inc.NDA 220049letter (PDF)n/a
Aug 6, 2025Immedica Pharma ABBLA 761211letter (PDF)n/a
Aug 5, 2025Accord BioPharma, Inc.BLA 761147letter (PDF)n/a
Jul 30, 2025Conjupro Biotherapeutics Inc.NDA 218923letter (PDF)n/a
Jul 30, 2025Regeneron Pharmaceuticals, Inc.BLA 761303letter (PDF)n/a
Jul 30, 2025Teva Pharmaceuticals, Inc.BLA 761385letter (PDF)n/a
Jul 28, 2025Heritage Pharmaceuticals Inc. d/b/a/ Avet PhNDA 205508letter (PDF)n/a
Jul 21, 2025Replimune, Inc.BL 125827letter (PDF)decision page
Jul 9, 2025Capricor, Inc.BL 125842letter (PDF)decision page
Jul 7, 2025Ultragenyx Pharmaceutical Inc.BL 125845letter (PDF)decision page
Jun 27, 2025Unicycive Therapeutics Inc.NDA 218607letter (PDF)decision page
Jun 26, 2025Accord BioPharma Inc.BLA 761027letter (PDF)n/a
Jun 25, 2025Sun Pharmaceutical Industries LimitedNDA 215644letter (PDF)n/a
Jun 20, 2025Cipla USA, Inc.NDA 210168letter (PDF)n/a
Jun 2, 2025ResQ PharmaNDA 217382letter (PDF)n/a
May 29, 2025Chemo Research, S.L.NDA 219029letter (PDF)n/a
May 15, 2025Stealth BioTherapeutics Inc.NDA 215244letter (PDF)n/a
Apr 25, 2025Fresenius Kabi USA, LLCNDA 215818letter (PDF)n/a
Apr 25, 2025University of California San FranciscoNDA 218353letter (PDF)n/a
Apr 25, 2025Telix Pharmaceuticals (US) Inc.NDA 218592letter (PDF)decision page
Apr 2, 2025Aldeyra Therapeutics, Inc.NDA 216442letter (PDF)n/a
Apr 2, 2025Amneal EU, LimitedNDA 218345letter (PDF)n/a
Mar 27, 2025Milestone Pharmaceuticals USA, Inc.NDA 218571letter (PDF)n/a
Mar 26, 2025CELLTRION, Inc.BLA 761377letter (PDF)n/a
Mar 20, 2025Jiangsu Hengrui Pharmaceuticals Co., LtdBLA 761308letter (PDF)n/a
Mar 20, 2025Elevar Therapeutics, Inc.NDA 216586letter (PDF)n/a
Mar 13, 2025Accord BioPharma Inc.BLA 761424letter (PDF)n/a
Mar 11, 2025Seikagaku CorporationBLA 761393letter (PDF)n/a
Mar 10, 2025Laurus Generics, Inc.NDA 217719letter (PDF)n/a
Jan 31, 2025SFJ Pharmaceuticals, Inc.BLA 761290letter (PDF)n/a
Jan 17, 2025Hospira, Inc.NDA 219112letter (PDF)n/a
Jan 15, 2025Atara Biotherapeutics, Inc.BL 125745letter (PDF)n/a
Jan 3, 2025OWP Pharmaceuticals, Inc.NDA 218879letter (PDF)n/a
Jan 3, 2025Tanvex BioPharma USA, Inc.BLA 761266letter (PDF)n/a

2024 · 69 letters

DateCompanyApplicationLetterOn this site
Dec 23, 2024Hikma Pharmaceuticals USA Inc.NDA 219357letter (PDF)n/a
Dec 20, 2024Lexicon Pharmaceuticals, Inc.NDA 210934letter (PDF)n/a
Dec 19, 2024Zealand Pharma US, Inc.NDA 218828letter (PDF)n/a
Dec 17, 2024CELLTRION, Inc.BLA 761338/Original 2, BLA 7letter (PDF)n/a
Dec 13, 2024Janssen Biotech, Inc.BLA 761433letter (PDF)n/a
Dec 11, 2024Meitheal Pharmaceuticals Inc.NDA 212271letter (PDF)n/a
Dec 11, 2024Fresenius Kabi USA, LLCNDA 214610letter (PDF)n/a
Dec 5, 2024Sandoz Inc.BLA 761271letter (PDF)n/a
Dec 5, 2024Accord Healthcare Inc.NDA 218762letter (PDF)n/a
Nov 27, 2024Applied Therapeutics, Inc.NDA 219195letter (PDF)n/a
Nov 15, 2024Astellas Pharma US, IncNDA 217225/S-001letter (PDF)n/a
Nov 14, 2024Lupin Limited (Biotech Division)BLA 761212letter (PDF)n/a
Nov 4, 2024Azurity Pharmaceuticals, Inc.NDA 219122letter (PDF)n/a
Oct 29, 2024Accord BioPharma Inc.BLA 761147letter (PDF)n/a
Oct 25, 2024Sun Pharmaceutical Industries LimitedNDA 215644letter (PDF)n/a
Oct 21, 2024Bridge Regulatory Affairs, LLCNDA 218600letter (PDF)n/a
Oct 21, 2024Hikma Pharmaceuticals USA Inc.NDA 219045letter (PDF)n/a
Oct 10, 2024Conjupro Biotherapeutics, Inc.NDA 218923letter (PDF)n/a
Oct 8, 2024Zealand Pharma US, Inc.NDA 217724/Original 1, NDA 2letter (PDF)n/a
Oct 7, 2024CSL Behring LLCBLA 761367letter (PDF)n/a
Sep 30, 2024Celltrion Inc.BLA 761338letter (PDF)n/a
Aug 20, 2024Regeneron Pharmaceuticals, Inc.BLA 761400letter (PDF)n/a
Aug 19, 2024Scienture Inc.NDA 218772letter (PDF)n/a
Aug 16, 2024Antares Pharma, Inc.NDA 218026letter (PDF)n/a
Aug 8, 2024Lykos TherapeuticsNDA 215455letter (PDF)n/a
Jul 26, 2024RB Health (US) LLCNDA 217338letter (PDF)n/a
Jul 25, 2024Xspray Pharma ABNDA 216195letter (PDF)n/a
Jul 15, 2024Orexo ABNDA 217433letter (PDF)n/a
Jul 11, 2024MEDRx USA, Inc.NDA 215029letter (PDF)n/a
Jul 10, 2024Novo Nordisk Inc.BLA 761326letter (PDF)n/a
Jul 4, 2024Samsung Bioepis Co., Ltd.BLA 761373/Original 2, BLA 7letter (PDF)n/a
Jul 1, 2024Amneal EU, Ltd.NDA 218345letter (PDF)n/a
Jun 27, 2024CELLTRION, Inc.BLA 761377letter (PDF)n/a
Jun 26, 2024Daiichi Sankyo, Inc.BLA 761366letter (PDF)n/a
Jun 18, 2024AbbVie Inc.NDA 216962letter (PDF)n/a
Jun 14, 2024Rocket Pharmaceuticals, Inc.BL 125806letter (PDF)n/a
Jun 14, 2024Nanocopoeia, LLCNDA 217379letter (PDF)n/a
Jun 13, 2024Bayer HealthCare LLCNDA 218506letter (PDF)n/a
Jun 12, 2024XTM Consulting LLCNDA 218698letter (PDF)n/a
May 24, 2024NeuroDerm, Ltd.NDA 218317letter (PDF)n/a
May 16, 2024Jiangsu Hengrui Pharmaceuticals Co., Ltd.BLA 761308letter (PDF)n/a
May 16, 2024Elevar Therapeutics, Inc.NDA 216586letter (PDF)n/a
May 10, 2024Accord Healthcare Inc.NDA 216987letter (PDF)n/a
Apr 19, 2024Dr. Reddy’s Laboratories SABLA 761376letter (PDF)n/a
Apr 19, 2024Xbrane Biopharma ABBLA 761187letter (PDF)n/a
Apr 17, 2024Accord Healthcare Inc.NDA 218762letter (PDF)n/a
Apr 16, 2024Abeona Therapeutics, Inc.BL 125807letter (PDF)n/a
Apr 12, 2024Gan & Lee PharmaceuticalsBLA 761356letter (PDF)n/a
Apr 5, 2024Accord BioPharma Inc.BLA 761147letter (PDF)n/a
Mar 29, 2024Baxter Healthcare CorporationNDA 218224letter (PDF)n/a
Mar 29, 2024Fidelity BioPharma Co.NDA 216190letter (PDF)n/a
Mar 27, 2024Baxter Healthcare CorporationNDA 218408letter (PDF)n/a
Mar 26, 2024Gan & Lee PharmaceuticalsBLA 761357letter (PDF)n/a
Mar 22, 2024Cipla USA, Inc.NDA 210168letter (PDF)n/a
Mar 22, 2024Regeneron Pharmaceuticals, Inc.BLA 761303/Original 1letter (PDF)n/a
Mar 22, 2024Regeneron Pharmaceuticals, Inc.BLA 761303/Original 2letter (PDF)n/a
Mar 8, 2024Mapi Pharma Ltd.NDA 218223letter (PDF)n/a
Mar 7, 2024Accord Healthcare Inc.NDA 215749letter (PDF)n/a
Feb 26, 2024Minerva Neurosciences, IncNDA 217002letter (PDF)n/a
Feb 22, 2024Venatorx Pharmaceuticals, Inc.NDA 217556letter (PDF)n/a
Feb 9, 2024Xeris Pharmaceuticals, Inc.NDA 212097/S-012letter (PDF)n/a
Jan 30, 2024Accord Healthcare Inc.NDA 218470letter (PDF)n/a
Jan 25, 2024Defender Pharmaceuticals, IncNDA 214315letter (PDF)n/a
Jan 25, 2024AFT Pharmaceuticals LtdNDA 218528letter (PDF)n/a
Jan 23, 2024Hikma Pharmaceuticals USA, Inc.NDA 218258letter (PDF)n/a
Jan 19, 2024Akeso Biopharma Co., Ltd.BLA 761258letter (PDF)n/a
Jan 17, 2024BendaRx USA CorporationNDA 215291letter (PDF)n/a
Jan 12, 2024SQ Innovation, Inc.NDA 217294letter (PDF)n/a
Jan 4, 2024Astellas Pharma US, Inc.BLA 761365letter (PDF)n/a

2023 · 29 letters

DateCompanyApplicationLetterOn this site
Dec 18, 2023CooperSurgical, Inc.NDA 018680/S-074letter (PDF)n/a
Dec 15, 2023Checkpoint Therapeutics, IncorporatedBLA 761297letter (PDF)n/a
Oct 11, 2023Alvotech USA Inc.BLA 761343letter (PDF)n/a
Sep 29, 2023Galderma R&D, LLCBLA 761311letter (PDF)n/a
Sep 28, 2023Eli Lilly and CompanyBLA 761306letter (PDF)n/a
Sep 22, 2023Botanix SB Inc.NDA 217347letter (PDF)n/a
Sep 19, 2023ARS Pharmaceuticals, Inc.NDA 214697letter (PDF)n/a
Aug 1, 2023Shilpa Medicare LimitedNDA 212782letter (PDF)n/a
Aug 1, 2023Mesoblast, Inc.BL 125706letter (PDF)n/a
Jul 28, 2023Citius Pharmaceuticals, Inc.BLA 761312letter (PDF)n/a
Jun 30, 2023Impax Laboratories, LLCNDA 217186letter (PDF)n/a
Jun 28, 2023Alvotech USA, Inc.BLA 761299letter (PDF)n/a
Jun 27, 2023Regeneron Pharmaceuticals, Inc.BLA 761355letter (PDF)n/a
May 31, 2023Fresenius Kabi USA, LLCBLA 761275letter (PDF)n/a
May 31, 2023AOP Orphan Pharmaceuticals GmbHNDA 217202letter (PDF)n/a
May 5, 2023Galephar Pharmaceutical Research Inc.NDA 215040letter (PDF)n/a
Apr 28, 2023Ascendis Pharma Bone Diseases A/SNDA 216490letter (PDF)n/a
Apr 24, 2023Novo NordiskBLA 761315letter (PDF)n/a
Apr 12, 2023Hugel, IncBLA 761225letter (PDF)n/a
Mar 30, 2023Eli Lilly and CompanyBLA 761279letter (PDF)n/a
Mar 17, 2023AbbVie Inc.NDA 216962letter (PDF)n/a
Mar 3, 2023Zydus Worldwide DMCCNDA 211566letter (PDF)n/a
Feb 14, 2023Tanvex BioPharma USA, Inc.BLA 761126letter (PDF)n/a
Feb 7, 2023Phathom Pharmaceuticals, Inc.NDA 215151letter (PDF)n/a
Jan 20, 2023StemCyte, Inc.BL 125764letter (PDF)n/a
Jan 18, 2023Eli Lilly and CompanyBLA 761248letter (PDF)n/a
Jan 13, 2023Mylan Pharmaceuticals Inc., a Viatris CompanNDA 204311letter (PDF)n/a
Jan 13, 2023Almatica Pharma, LLCNDA 215721letter (PDF)n/a
Jan 6, 2023Liqmeds Worldwide LimitedNDA 216482letter (PDF)n/a

2022 · 22 letters

DateCompanyApplicationLetterOn this site
Dec 23, 2022lpsen Biopharmaceuticals Inc.NDA 215559letter (PDF)n/a
Dec 20, 2022Alvotech USA, Inc.BLA 761299letter (PDF)n/a
Nov 23, 2022Celitrion, Inc.BLA 761219letter (PDF)n/a
Oct 19, 2022Spes Pharmaceuticals Inc.NDA 216686letter (PDF)n/a
Aug 4, 2022CorMedix Inc.NDA 214520letter (PDF)n/a
Jun 30, 2022AFT Pharmaceuticals Ltd.NDA 215320letter (PDF)n/a
Jun 15, 2022Acer Therapeutics Inc.NDA 214860letter (PDF)n/a
Jun 6, 2022Braintree Laboratories, Inc.NDA 215344letter (PDF)n/a
May 23, 2022Verrica Pharmaceuticals Inc.NDA 212905letter (PDF)n/a
May 12, 2022UGB, Inc.BLA 761151letter (PDF)n/a
Apr 29, 2022Coherus BioSciences, Inc.BLA 761240letter (PDF)n/a
Apr 28, 2022CMP Development LLCNDA 214952letter (PDF)n/a
Apr 18, 2022Dr. Reddy’s Laboratories LimitedNDA 210852letter (PDF)n/a
Apr 15, 2022Teva Neuroscience, Inc.NDA 213586letter (PDF)n/a
Apr 14, 2022Shilpa Medicare LimitedNDA 215179letter (PDF)n/a
Mar 31, 2022Hugel, IncBLA 761225letter (PDF)n/a
Mar 29, 2022Akebia Therapeutics, Inc.NDA 215192letter (PDF)n/a
Feb 26, 2022Amryt Pharmaceuticals DACNDA 215064letter (PDF)n/a
Feb 25, 2022Green Cross CorporationBL 125743letter (PDF)n/a
Feb 18, 2022Shandong Luye Pharmaceutical Co., Ltd.NDA 212849letter (PDF)n/a
Feb 18, 2022Mallinckrodt Pharmaceuticals Ireland LtdNDA 022231letter (PDF)n/a
Jan 21, 2022Pfizer Ireland PharmaceuticalsBLA 761184letter (PDF)n/a

2021 · 45 letters

DateCompanyApplicationLetterOn this site
Dec 17, 2021Eli Lilly and CompanyBLA 761215/Original 2, BLA 7letter (PDF)n/a
Dec 17, 2021Takeda Pharmaceuticals U.S.A., Inc.NDA 213976letter (PDF)n/a
Dec 15, 2021Braeburn Inc.NDA 210136letter (PDF)n/a
Nov 26, 2021Fennec Pharmaceuticals, Inc.NDA 212937letter (PDF)n/a
Nov 24, 2021Celitrion, Inc.BLA 761219letter (PDF)n/a
Nov 19, 2021Bio-Thera Solutions Ltd.BLA 761198letter (PDF)n/a
Nov 9, 2021Santen, Inc.NDA 215092letter (PDF)n/a
Oct 22, 2021Eyenovia, Inc.NDA 215352letter (PDF)n/a
Oct 22, 2021Marius Pharmaceuticals, LLCNDA 213953letter (PDF)n/a
Oct 15, 2021United Therapeutics Corp.NDA 214324letter (PDF)n/a
Oct 15, 2021Omeros CorporationBLA 761152letter (PDF)n/a
Oct 14, 2021Revance Therapeutics, Inc.BLA 761127letter (PDF)n/a
Oct 5, 2021Polarean Inc.NDA 214375letter (PDF)n/a
Sep 16, 2021Verrica Pharmaceuticals Inc.NDA 212905letter (PDF)n/a
Sep 14, 2021HQ Specialty Pharma CorporationNDA 215212letter (PDF)n/a
Sep 2, 2021Zydus Worldwide DMCCNDA 211566letter (PDF)n/a
Aug 25, 2021Zhejiang Novus Pharmaceuticals Co. Ltd.NDA 210274letter (PDF)n/a
Aug 18, 2021CellTrans Inc.BL 125734letter (PDF)n/a
Aug 11, 2021Kashiv BioSciences, LLCBLA 761084letter (PDF)n/a
Aug 5, 2021LLCNDA 214952letter (PDF)n/a
Aug 3, 2021Spectrum Pharmaceuticals, Inc.BLA 761148letter (PDF)n/a
Aug 2, 2021Kashiv BioSciences, LLCBLA 761082letter (PDF)n/a
Jul 30, 2021medac Gesellschaft fur klinische SpezialprapNDA 214759letter (PDF)n/a
Jul 28, 2021Ardelyx, Inc.NDA 213931letter (PDF)n/a
Jul 23, 2021lterum Therapeutics U.S. Ltd.NDA 213972letter (PDF)n/a
Jul 2, 2021Provention Bio, Inc.BLA 761183letter (PDF)n/a
Jun 25, 2021Cyclomedica Australia Pty Ltd.NDA 022335letter (PDF)n/a
Jun 25, 2021MediWound, Ltd.BLA 761192letter (PDF)n/a
Jun 24, 2021Shilpa Medicare LimitedNDA 215179letter (PDF)n/a
Jun 17, 2021Orphazyme A/SNDA 214927letter (PDF)n/a
Jun 14, 2021Nevakar, Inc.NDA 214628letter (PDF)n/a
May 28, 2021Azurity Pharmaceuticals, Inc.NDA 214273letter (PDF)n/a
May 20, 2021Tanvex BioPharma USA, Inc.BLA 761126letter (PDF)n/a
Apr 30, 2021Accord Healthcare, Inc.NDA 215000letter (PDF)n/a
Apr 29, 2021Baxter Healthcare CorporationNDA 213645letter (PDF)n/a
Apr 27, 2021Chiesi USABLA 761161letter (PDF)n/a
Apr 23, 2021LEO Pharma A/SBLA 761180letter (PDF)n/a
Apr 22, 2021CMP Development LLCNDA 214439letter (PDF)n/a
Mar 12, 2021PharmaEssentia CorporationBLA 761166letter (PDF)n/a
Feb 26, 2021CorMedix Inc.NDA 214520letter (PDF)n/a
Feb 23, 2021CMP Development LLCNDA 214522letter (PDF)n/a
Feb 12, 2021Novitium Pharma LLCNDA 214581letter (PDF)n/a
Jan 28, 2021Azurity Pharmaceuticals, Inc.NDA 213593letter (PDF)n/a
Jan 21, 2021Emory Partners, LLCNDA 210526letter (PDF)n/a
Jan 8, 2021HQ Specialty Pharma CorporationNDA 211413letter (PDF)n/a

2020 · 36 letters

DateCompanyApplicationLetterOn this site
Dec 22, 2020Kashiv BioSciences, LLCBLA 761082letter (PDF)n/a
Dec 22, 2020InnoPharma Licensing LLCNDA 206968letter (PDF)n/a
Dec 18, 2020Novartis Pharmaceuticals CorporationNDA 214012letter (PDF)n/a
Dec 3, 2020scPharmaceuticals Services, IncNDA 209988letter (PDF)n/a
Dec 1, 2020Braeburn Inc.NDA 210136letter (PDF)n/a
Nov 27, 2020Zhejiang Novus Pharmaceuticals Co. Ltd.NDA 210274letter (PDF)n/a
Nov 23, 2020Genentech, IncorporatedNDA 214410/Original 2, NDA 2letter (PDF)n/a
Nov 13, 2020Adamis Pharmaceuticals CorporationNDA 212854letter (PDF)n/a
Nov 13, 2020Bioverativ USA, Inc.BLA 761164letter (PDF)n/a
Nov 13, 2020Alkermes, Inc.NDA 213378/Original 1, NDA 2letter (PDF)n/a
Nov 12, 2020sanofi-aventis U.S. LLCNDA 214429letter (PDF)n/a
Nov 6, 2020AFT Pharmaceuticals, Inc.NDA 209471letter (PDF)n/a
Nov 6, 2020Dr. Reddy’s Laboratories LimitedNDA 210852letter (PDF)n/a
Nov 6, 2020Supernus Pharmaceuticals, Inc.NDA 211964letter (PDF)n/a
Oct 16, 2020CMP Development LLCNDA 213260letter (PDF)n/a
Sep 11, 2020Mallinckrodt Hospital Products IP LimitedNDA 022231letter (PDF)n/a
Aug 13, 2020Nobelpharma Co., Ltd.NDA 213478letter (PDF)n/a
Aug 10, 2020Fennec Pharmaceuticals, Inc.NDA 212937letter (PDF)n/a
Aug 3, 2020DBV Technologies S.A.BL 125713letter (PDF)n/a
Jul 23, 2020Corium, Inc.NDA 212304letter (PDF)n/a
Jul 13, 2020Verrica Pharmaceuticals Inc.NDA 212905letter (PDF)n/a
Jun 26, 2020Heron Therapeutics, Inc.NDA 211988letter (PDF)n/a
Jun 15, 2020Esteve Pharmaceuticals, S.A.NDA 213426letter (PDF)n/a
May 26, 2020Althera Life Sciences, LLCNDA 213072letter (PDF)n/a
May 21, 2020Dr. Reddy’s Laboratories LimitedNDA 210852letter (PDF)n/a
May 18, 2020Par Sterile Products, LLCNDA 212156letter (PDF)n/a
Apr 24, 2020B. Braun Medical, Inc.NDA 204957letter (PDF)n/a
Mar 24, 2020IntelGenx Corp.NDA 205394letter (PDF)n/a
Mar 20, 2020Xellia Pharmaceuticals, ApSNDA 213895letter (PDF)n/a
Mar 13, 2020Braintree Laboratories, Inc.NDA 213135letter (PDF)n/a
Mar 10, 2020Shilpa Medicare LimitedNDA 212782letter (PDF)n/a
Feb 28, 2020Hikma Pharmaceuticals USA Inc.NDA 212045letter (PDF)n/a
Jan 28, 2020Shandong Luye Pharmaceutical Co., Ltd.NDA 212849letter (PDF)n/a
Jan 28, 2020Recordati Rare Diseases Inc.NDA 211302letter (PDF)n/a
Jan 14, 2020Ingenus Pharmaceuticals, LLCNDA 212501letter (PDF)n/a
Jan 10, 2020Sarfez Pharmaceuticals Inc.NDA 213218letter (PDF)n/a

2019 · 34 letters

DateCompanyApplicationLetterOn this site
Dec 26, 2019HQ Specialty Pharma CorporationNDA 211413letter (PDF)n/a
Dec 20, 2019Sedor Pharmaceuticals, LLCNDA 210864letter (PDF)n/a
Dec 17, 2019Takeda Pharmaceuticals, U.S.A., Inc.BLA 761133letter (PDF)n/a
Nov 22, 2019Adamis Pharmaceuticals CorporationNDA 212854letter (PDF)n/a
Nov 20, 2019Dr. Reddy’s Laboratories LimitedNDA 210852letter (PDF)n/a
Oct 18, 2019Clearside Biomedical, Inc.NDA 211950letter (PDF)n/a
Oct 1, 2019AuroMedics Pharma LLCNDA 210735letter (PDF)n/a
Sep 30, 2019AstraZeneca ABNDA 212122letter (PDF)n/a
Sep 24, 2019Tanvex BioPharma USA, Inc.BLA 761126letter (PDF)n/a
Aug 28, 2019Mylan GmbHNDA 210605letter (PDF)n/a
Aug 19, 2019Sarepta Therapeutics, Inc.NDA 211970letter (PDF)n/a
Aug 14, 2019Bioprojet PharmaNDA 211150/Original 2, NDA 2letter (PDF)n/a
Aug 7, 2019Kala Pharmaceuticals, Inc.NDA 210933letter (PDF)n/a
Aug 6, 2019Mylan Pharmaceuticals Inc.NDA 204311letter (PDF)n/a
Jul 19, 2019Bausch Health Ireland LimitedNDA 211039letter (PDF)n/a
Jul 18, 2019Ricon Pharma, LLCNDA 212501letter (PDF)n/a
Jun 20, 2019Glenmark Pharmaceuticals, Inc.NDA 211746letter (PDF)n/a
Jun 19, 2019Chiesi USA, Inc.NDA 202049letter (PDF)n/a
Jun 11, 2019Kashiv BioSciences, LLCBLA 761082letter (PDF)n/a
Jun 6, 2019Mylan Laboratories LimitedNDA 206610letter (PDF)n/a
May 3, 2019Dr. Reddy’s Laboratories, IncNDA 210852letter (PDF)n/a
May 2, 2019Acacia Pharma LtdNDA 209510letter (PDF)n/a
Apr 30, 2019Heron Therapeutics, Inc.NDA 211988letter (PDF)n/a
Apr 1, 2019Evoke Pharma, Inc.NDA 209388letter (PDF)n/a
Mar 29, 2019Proximagen, LLCNDA 211321letter (PDF)n/a
Mar 28, 2019IntelGenx Corp.NDA 205394letter (PDF)n/a
Mar 28, 2019Fera Pharmaceuticals, LLCNDA 202408letter (PDF)n/a
Mar 27, 2019B. Braun Medical, Inc.NDA 204957letter (PDF)n/a
Mar 22, 2019Recro Pharma Inc.NDA 210583letter (PDF)n/a
Mar 22, 2019Sedor Pharmaceuticals, LLCNDA 210864letter (PDF)n/a
Jan 29, 2019Sunovion Pharmaceuticals Inc.NDA 210875letter (PDF)n/a
Jan 23, 2019Vero Biotech, LLCNDA 202860letter (PDF)n/a
Jan 17, 2019Immunomedics, IncBLA 761115letter (PDF)n/a
Jan 15, 2019AuroMedics Pharma LLCNDA 210735letter (PDF)n/a

2018 · 33 letters

DateCompanyApplicationLetterOn this site
Dec 21, 2018Braeburn Pharmaceuticals Inc.NDA 210136letter (PDF)n/a
Dec 12, 2018International Medication Systems, LimitedNDA 211363letter (PDF)n/a
Nov 30, 2018Innocoll PharmaceuticalsNDA 209511letter (PDF)n/a
Nov 20, 2018Valeant Pharmaceuticals IrelandNDA 210821letter (PDF)n/a
Nov 9, 2018InnoPharma Licensing LLCNDA 206968letter (PDF)n/a
Nov 2, 2018Trevena, Inc.NDA 210730letter (PDF)n/a
Oct 19, 2018HQ Specialty Pharma CorporationNDA 211413letter (PDF)n/a
Oct 5, 2018Acacia Pharma LtdNDA 209510letter (PDF)n/a
Sep 12, 2018AB Pharmaceuticals, LLCNDA 210649letter (PDF)n/a
Aug 24, 2018Daiichi Sankyo Inc.NDA 210895letter (PDF)n/a
Jul 25, 2018Tris Pharma, Inc.NDA 210526letter (PDF)n/a
Jul 24, 2018Dr. Reddy’s Laboratories, IncNDA 210852letter (PDF)n/a
Jul 20, 2018Lannett Holdings, Inc.NDA 209575letter (PDF)n/a
Jun 26, 2018Actavis LLC, an indirect, wholly-owned subsiNDA 208419letter (PDF)n/a
Jun 25, 2018Metacel Pharmaceuticals, LLCNDA 208193letter (PDF)n/a
Jun 15, 2018Zhejiang Novus Pharmaceuticals Co. Ltd.NDA 210274letter (PDF)n/a
Jun 15, 2018Dow Pharmaceutical Sciences, Inc.NDA 209354letter (PDF)n/a
Jun 11, 2018scPharmaceuticals, Inc.NDA 209988letter (PDF)n/a
May 25, 2018Amgen Inc.BLA 761073letter (PDF)n/a
May 23, 2018Recro Pharma Inc.NDA 210583letter (PDF)n/a
May 17, 2018Mylan GmbHNDA 210605letter (PDF)n/a
May 15, 2018Evolus, Inc.BLA 761085letter (PDF)n/a
May 10, 2018Adello Biologics, LLCBLA 761082letter (PDF)n/a
Apr 26, 2018AuroMedics Pharma LLCNDA 210735letter (PDF)n/a
Apr 20, 2018Pfizer Inc.BLA 761081letter (PDF)n/a
Mar 30, 2018CELLTRION, Inc.BLA 761091letter (PDF)n/a
Mar 23, 2018Samsung Bioepis Co., Ltd.BLA 761066letter (PDF)n/a
Mar 22, 2018Clarus Therapeutics, Inc.NDA 206089letter (PDF)n/a
Mar 19, 2018Hospira, Inc.NDA 210282letter (PDF)n/a
Mar 13, 2018AB Pharmaceuticals, LLCNDA 210649letter (PDF)n/a
Feb 28, 2018CELLTRION, Inc.BLA 761088letter (PDF)n/a
Feb 22, 2018Hospira, Inc.NDA 209191letter (PDF)n/a
Jan 19, 2018Braeburn Pharmaceuticals Inc.NDA 210136letter (PDF)n/a

2017 · 24 letters

DateCompanyApplicationLetterOn this site
Dec 22, 2017AFT Pharmaceuticals, Ltd.NDA 209471letter (PDF)n/a
Dec 21, 2017Agile Therapeutics, Inc.NDA 204017letter (PDF)n/a
Dec 6, 2017Mylan Laboratories LimitedNDA 206610letter (PDF)n/a
Nov 3, 2017Hospira, Inc.NDA 209191letter (PDF)n/a
Oct 26, 2017Teva Pharmaceuticals USA, Inc.NDA 210063letter (PDF)n/a
Oct 20, 2017Antares Pharma, Inc.NDA 209863letter (PDF)n/a
Oct 11, 2017AcelRx Pharmaceuticals, Inc.NDA 209128letter (PDF)n/a
Sep 28, 2017B. Braun Medical, Inc.NDA 204957letter (PDF)n/a
Sep 26, 2017Actavis, L.L.C.NDA 208419letter (PDF)n/a
Sep 1, 20173M Health Care (Infection Prevention DivisioNDA 208288letter (PDF)n/a
Aug 28, 2017Astellas Pharma US, Inc.NDA 209529letter (PDF)n/a
Jul 28, 2017Ironshore Pharmaceuticals & Development, IncNDA 209311letter (PDF)n/a
Jul 13, 2017Amgen Inc.BLA 761062letter (PDF)n/a
Jul 10, 2017Ocular Therapeutix, Inc.NDA 208742letter (PDF)n/a
Jun 9, 2017Coherus BioSciences, Inc.BLA 761039letter (PDF)n/a
Jun 2, 2017United Therapeutics CorporationNDA 208276letter (PDF)n/a
May 23, 2017Sun Pharmaceutical Industries LimitedNDA 208313letter (PDF)n/a
May 5, 2017TherapeuticsMD, Inc.NDA 208564letter (PDF)n/a
Apr 26, 2017Hospira, Inc.NDA 209191letter (PDF)n/a
Mar 24, 2017Institut Biochimique SA (IBSA)NDA 206976letter (PDF)n/a
Mar 22, 2017Sun Pharma Advanced Research Company LimitedNDA 204417letter (PDF)n/a
Feb 17, 2017Amphastar Pharmaceuticals, Inc.NDA 208969letter (PDF)n/a
Feb 1, 2017Mylan Laboratories LimitedNDA 206610letter (PDF)n/a
Jan 11, 2017Metacel Pharmaceuticals, LLCNDA 208193letter (PDF)n/a

2016 · 19 letters

DateCompanyApplicationLetterOn this site
Dec 23, 2016Armstrong Pharmaceuticals, Inc.NDA 205920letter (PDF)n/a
Dec 19, 2016Sun Pharma Advanced Research Company LimitedNDA 206185letter (PDF)n/a
Nov 23, 2016Ferring Pharmaceuticals, Inc.NDA 201110letter (PDF)n/a
Nov 15, 2016InnoPharma Licensing LLCNDA 206968letter (PDF)n/a
Oct 7, 2016United Therapeutics CorporationNDA 208276letter (PDF)n/a
Sep 30, 2016Teva Pharmaceuticals USANDA 208042letter (PDF)n/a
Sep 15, 2016The Feinstein Institute for Medical ResearchNDA 200655letter (PDF)n/a
Aug 30, 2016Dr. Reddy’s Laboratories, SANDA 206966letter (PDF)n/a
Jul 21, 2016Ocular Therapeutix, Inc.NDA 208742letter (PDF)n/a
Jun 24, 2016Fera Pharmaceuticals, LLCNDA 202408letter (PDF)n/a
Jun 24, 2016Sandoz Inc.BLA 761045letter (PDF)n/a
Jun 22, 2016Salamandra, LLCNDA 208647letter (PDF)n/a
May 27, 2016Teva Pharmaceuticals, Inc.NDA 208082letter (PDF)n/a
May 10, 2016Scilex Pharmaceuticals, Inc.NDA 207962letter (PDF)n/a
May 6, 20163M Health Care (Infection Prevention DivisioNDA 208288letter (PDF)n/a
May 4, 2016Dr. Reddy’s Laboratories, Limited-NDA 206927/Original 1, NDA 2letter (PDF)n/a
Apr 28, 2016Evofem, Inc.NDA 208352letter (PDF)n/a
Apr 15, 2016Camargo Pharmaceutical ServicesNDA 208232letter (PDF)n/a
Mar 10, 2016Mylan Laboratories LimitedNDA 206610letter (PDF)n/a

2015 · 9 letters

DateCompanyApplicationLetterOn this site
Dec 9, 2015Belcher Pharmaceuticals, LLC.NDA 207987letter (PDF)n/a
Nov 24, 2015Sun Pharmaceutical Industries LimitedNDA 208313letter (PDF)n/a
Sep 23, 2015Sun Pharma Advanced Research Company LimitedNDA 204417letter (PDF)n/a
Aug 27, 2015Amgen, Inc.BLA 125522letter (PDF)n/a
Jul 30, 2015Sun Pharma Advanced Research Company LimitedNDA 206185letter (PDF)n/a
May 29, 2015ELC GroupNDA 205054letter (PDF)n/a
Feb 27, 2015Mylan Pharmaceuticals, Inc.NDA 206610letter (PDF)n/a
Feb 27, 2015nnoPharma Licensing LLCNDA 206968letter (PDF)n/a
Jan 30, 2015Ferring Pharmaceuticals Inc.NDA 022517letter (PDF)n/a

2014 · 8 letters

DateCompanyApplicationLetterOn this site
Dec 17, 2014Dr. Reddy’s Laboratories, Limited-NDA 206927/Original 1, NDA 2letter (PDF)n/a
Nov 24, 2014Sun Pharma Advanced Research Company LimitedNDA 206185letter (PDF)n/a
Nov 3, 2014Clarus Therapeutics, Inc.NDA 206089letter (PDF)n/a
Oct 23, 2014Mylan Pharmaceuticals Inc.NDA 204311letter (PDF)n/a
May 22, 2014Armstrong PharmaceuticalsNDA 205920letter (PDF)n/a
Mar 31, 2014Fera Pharmaceuticals, LLCNDA 202408letter (PDF)n/a
Feb 12, 2014DURECT CorporationNDA 204803letter (PDF)n/a
Jan 31, 2014RedHill Biopharma Ltd.NDA 205394letter (PDF)n/a

2013 · 12 letters

DateCompanyApplicationLetterOn this site
Nov 4, 2013NorthStar Medical Radioisotopes, LLCNDA 202158letter (PDF)n/a
Oct 22, 2013Thomas Chaly, Ph.D., FAICNDA 200655letter (PDF)n/a
Sep 12, 2013Delcath Systems, IncorporatedNDA 201848letter (PDF)n/a
Jul 17, 2013Agile Therapeutics, Inc.NDA 204017letter (PDF)n/a
Jun 28, 2013Merck & Co., Inc.NDA 204569letter (PDF)n/a
Jun 28, 2013GeNO LLCNDA 202860letter (PDF)n/a
Jun 6, 2013AVEO Pharmaceuticals, Inc.NDA 204408letter (PDF)n/a
May 3, 2013Roxane Laboratories, Inc.NDA 203856letter (PDF)n/a
Mar 29, 2013Sun Pharma Global FZENDA 204417letter (PDF)n/a
Mar 18, 2013Pharmaxis Ltd.NDA 202049letter (PDF)n/a
Feb 13, 2013Agile Therapeutics, Inc.NDA 204017letter (PDF)n/a
Jan 30, 2013Ferring Pharmaceuticals Inc.NDA 022517letter (PDF)n/a

2012 · 4 letters

DateCompanyApplicationLetterOn this site
Jul 26, 2012Otsuka Pharmaceutical Company, Ltd.NDA 202971letter (PDF)n/a
May 18, 2012GeNO LLCNDA 202860letter (PDF)n/a
Mar 28, 2012Chelsea Therapeutics, Inc.NDA 203202letter (PDF)n/a
Jan 17, 2012Bristol-Myers SquibbNDA 202293letter (PDF)n/a

2011 · 2 letters

DateCompanyApplicationLetterOn this site
Feb 28, 2011Teva Women’s Health, Inc.NDA 201110letter (PDF)n/a
Feb 28, 2011EMD Serono, Inc.NDA 022561letter (PDF)n/a

2010 · 2 letters

DateCompanyApplicationLetterOn this site
Apr 22, 2010Ferring Pharmaceuticals Inc.NDA 022517letter (PDF)n/a
Feb 10, 2010Cadence PharmaceuticalsNDA 022450letter (PDF)n/a

2009 · 2 letters

DateCompanyApplicationLetterOn this site
Nov 4, 2009Orphan Therapeutics, LLCNDA 022231letter (PDF)n/a
May 15, 2009King Pharmaceuticals, Inc.NDA 022377letter (PDF)n/a

2008 · 1 letter

DateCompanyApplicationLetterOn this site
Feb 25, 2008Kyowa Pharmaceutical, Inc.NDA 022075letter (PDF)n/a

2007 · 1 letter

DateCompanyApplicationLetterOn this site
Nov 2, 2007Fabre-Kramer Pharmaceuticals, Inc.NDA 021164letter (PDF)n/a

2004 · 1 letter

DateCompanyApplicationLetterOn this site
Jun 23, 2004Organon, Inc.NDA 021164letter (PDF)n/a

2002 · 1 letter

DateCompanyApplicationLetterOn this site
Mar 15, 2002Organon, Inc.NDA 021164letter (PDF)n/a

Questions

What is a Complete Response Letter?
A Complete Response Letter (CRL) is the FDA's formal notice that it will not approve a drug application in its current form. It lists the deficiencies the sponsor must address; it is not a permanent rejection, and many drugs are approved after resubmission.

How many FDA Complete Response Letters are published here?
444 letters, released by the FDA under its CRL transparency program and hosted on FDA's own servers. 159 were issued in 2024 or later; the rest go back as far as 2002.

Why does this page not show an approval rate after a CRL?
Because this corpus cannot answer that question honestly. Letters for pre-2024 applications were released because those drugs were LATER APPROVED, so nearly all of them precede an approval by construction. Letters from 2024 onward are too recent for many outcomes to exist yet. Counts are stated; rates from this data would mislead in both directions.

CRL decisions tracked by this site · the full decisions archive · what a PDUFA date is

About · Corrections · Methodology

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