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Home › Decisions › CRL letters

FDA complete response letter database: 458 released CRLs

Page updated ·next FDA decision on the calendar ·Data as of Oct 21, 2026 12:50 PM ET
This is a database of the 458 complete response letters the FDA has released under its CRL transparency program, published through openFDA; the FDA releases letters selectively, so the set is not every CRL ever issued. This page lists every released letter with a hosted file (455 distinct letters from 458 records), newest first, each linking the original PDF on FDA's servers. 160 listed 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 section below explains why a rate from this data would mislead.

What the FDA has released, and what it does and does not show

A complete response letter is the FDA's formal notice, at the end of a review cycle, that it will not approve an application in its current form. The letter lists the deficiencies. It is not a permanent rejection: the sponsor can resubmit, and the same application is often approved on a later cycle.

458 records in the FDA's release (openFDA transparency/crl, last updated 2026-08-26). openFDA labels 309 of them as letters to applications the FDA has since approved and 149 as letters to applications not approved as of the release. The FDA described its first batch (July 10, 2025) as decision letters “associated with since-approved applications”; later batches added letters for applications still unapproved.

Read the split by year before drawing anything from it. Nearly every letter dated 2023 or earlier is on a since-approved application, and nearly every letter from 2025 on is not. That is the shape of a release policy (archived letters for approved applications first, then everything from 2024 onward), not the shape of the odds. The corpus shows that an application which receives a CRL can be approved later, 309 times over; it cannot say how often that happens, and this site does not compute a rate from it.
Letter yearSince approvedNot approvedTotal
202603232
202505959
2024145569
202329130
202224024
202148048
202035136
201936036
201833033
201725025
201620020
2015909
2014808
201312012
2012404
2011202
2010202
2009202
2008101
2007101
2004101
2002101
All307148455
Counts of listed letters by openFDA's approval_status field; the 1 record without a hosted file and the 2 duplicate records are not in the table.

The release over time

The FDA adds letters to the release in batches. Each row is a dated capture of openFDA transparency/crl on which the record set differed from the previous capture; last checked 2026-10-21.
CapturedRecordsSince approvedNot approvedAdded since prior
2026-06-22439309130
2026-08-29458309149+19

2026 · 32 letters

DateCompanyApplicationLetterSections addressed (from the PDF)On this site
Aug 7, 2026ITM Solucin GmbHNDA 218705letter (PDF)Product Quality Microbiology; Facility Inspectionsn/a
Jul 21, 2026Apiject Systems Corp.NDA 219107letter (PDF)Drug-Device Combination Product Qualityn/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)Clinical/Statistical; Product Qualityn/a
Jun 29, 2026Ipsen Biopharm Ltd.BLA 761311letter (PDF)Facility Inspections; Product Quality; Microbiologyn/a
Jun 29, 2026Unicycive Therapeutics Inc.NDA 218607letter (PDF)Facility Inspectionsdecision page
Jun 26, 2026Evergreen Theragnostics, Inc.NDA 216900letter (PDF)Product Qualityn/a
Jun 26, 2026Swedish Orphan Biovitrum AB (publ)BLA 761438letter (PDF)Clinical Pharmacologyn/a
Jun 23, 2026Tanvex BioPharma USA, Inc.BLA 761266letter (PDF)·n/a
Jun 20, 2026Achieve Life Sciences, Inc.NDA 218995letter (PDF)Clinical Pharmacology; Nonclinicaldecision page
Jun 15, 2026Tris Pharma, Inc.NDA 220138letter (PDF)Clinical; Human Factorsn/a
Jun 10, 2026Bridge Regulatory Affairs, LLCNDA 218600letter (PDF)Facility Inspectionsn/a
Jun 4, 2026Xspray Pharma ABNDA 217644letter (PDF)Clinical Pharmacology; Product Quality; Facility Inspectionsn/a
May 29, 2026Cingulate Therapeutics, LLCNDA 220283letter (PDF)Product Quality; Facility Inspectionsdecision page
May 15, 2026Ocuvex Therapeutics, Inc.NDA 217363letter (PDF)Facility Inspectionsn/a
Apr 23, 2026Grace Therapeutics U.S., Inc.NDA 220304letter (PDF)Product Quality; Nonclinical; Facility Inspectionsdecision page
Apr 22, 2026AbbVie Inc.BLA 761459letter (PDF)Facility Inspections; Product Qualitydecision page
Apr 13, 2026Eagle Pharmaceuticals, Inc.NDA 220045letter (PDF)Facility Inspectionsn/a
Apr 10, 2026Replimune, Inc.BL 125827letter (PDF)Clinicaldecision page
Apr 10, 2026Telix Pharmaceuticals (US) Inc.BLA 761401letter (PDF)Product Quality; Microbiologyn/a
Mar 16, 2026Aldeyra Therapeutics, Inc.NDA 216442letter (PDF)·decision page
Mar 5, 2026Rosemont Pharmaceuticals Holdings, Inc.NDA 220140letter (PDF)·n/a
Feb 27, 2026Fresenius Kabi USA, LLCNDA 214610letter (PDF)Product Qualityn/a
Feb 27, 2026Ferring Pharmaceuticals Inc.BLA 761253letter (PDF)·n/a
Feb 27, 2026Fresenius Kabi USA, LLCNDA 215818letter (PDF)Product Qualityn/a
Feb 26, 2026Amphastar Pharmaceuticals, Inc.BLA 761403letter (PDF)Facility Inspections; Product Qualityn/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)Clinical Pharmacologyn/a
Jan 28, 2026Corcept TherapeuticsNDA 219398letter (PDF)·decision page
Jan 9, 2026Pierre Fabre Pharmaceuticals Inc.BL 125745letter (PDF)Clinical; Chemistry, Manufacturing, and Controlsn/a

2025 · 59 letters

DateCompanyApplicationLetterSections addressed (from the PDF)On this site
Dec 30, 2025Dr. Reddy’s Laboratories, Inc.BLA 761471letter (PDF)Facility Inspectionsn/a
Dec 30, 2025Outlook Therapeutics, Inc.BLA 761320letter (PDF)·decision page
Dec 23, 2025Genzyme CorporationNDA 219624letter (PDF)Risk Evaluation and Mitigation Strategy Requirementsn/a
Dec 22, 2025MedicaSafe, Inc.NDA 220184letter (PDF)Risk Evaluation and Mitigation Strategy Requirementsn/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)Clinicaln/a
Dec 9, 2025Sandoz Inc.BLA 761271letter (PDF)Microbiology; Facility Inspectionsn/a
Nov 26, 2025Alvotech USA Inc.BLA 761461letter (PDF)Product Qualityn/a
Nov 24, 2025Alvotech USA Inc.BLA 761435letter (PDF)Facility Inspectionsn/a
Nov 6, 2025Accord Healthcare Inc.NDA 216987letter (PDF)·n/a
Nov 4, 2025Biohaven Therapeutics, Ltd.NDA 210862letter (PDF)Nonclinicaln/a
Oct 31, 2025Alvotech USA Inc.BLA 761462letter (PDF)Product Qualityn/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)Chemistry, Manufacturing, and Controlsn/a
Oct 16, 2025Dr. Reddy’s Laboratories SABLA 761376letter (PDF)Microbiologyn/a
Oct 10, 2025AstraZeneca Pharmaceuticals LPBLA 761451letter (PDF)Clinical/Statisticaln/a
Oct 7, 2025Xspray Pharma ABNDA 216195letter (PDF)Facility Inspectionsn/a
Sep 30, 2025Sentynl Therapeutics, Inc.NDA 211241letter (PDF)·n/a
Sep 22, 2025Scholar Rock, Inc.BLA 761463letter (PDF)Facility Inspections; Product Qualityn/a
Sep 22, 2025Biogen, Inc.NDA 209531/S-016letter (PDF)·n/a
Aug 27, 2025Saol International Development LimitedNDA 218679letter (PDF)Clinical Pharmacology; Nonclinicaln/a
Aug 27, 2025Outlook Therapeutics, Inc.BLA 761320letter (PDF)·decision page
Aug 27, 2025Vyluma, Inc.NDA 217711letter (PDF)Clinical; Facility Inspectionsn/a
Aug 18, 2025PTC Therapeutics, Inc.NDA 220049letter (PDF)·n/a
Aug 6, 2025Immedica Pharma ABBLA 761211letter (PDF)Clinical; Product Quality; Clinical Pharmacologyn/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)Risk Evaluation and Mitigation Strategy Requirementsn/a
Jul 28, 2025Heritage Pharmaceuticals Inc. d/b/a/ Avet PhNDA 205508letter (PDF)Facility Inspections; Product Qualityn/a
Jul 21, 2025Replimune, Inc.BL 125827letter (PDF)Clinicaldecision page
Jul 9, 2025Capricor, Inc.BL 125842letter (PDF)·decision page
Jul 7, 2025Ultragenyx Pharmaceutical Inc.BL 125845letter (PDF)Clinicaldecision 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)Nonclinical; Human Factors; Product Qualityn/a
May 29, 2025Chemo Research, S.L.NDA 219029letter (PDF)no text layer (scanned PDF)n/a
May 15, 2025Stealth BioTherapeutics Inc.NDA 215244letter (PDF)Facility Inspectionsn/a
Apr 25, 2025Fresenius Kabi USA, LLCNDA 215818letter (PDF)Product Qualityn/a
Apr 25, 2025University of California San FranciscoNDA 218353letter (PDF)·n/a
Apr 25, 2025Telix Pharmaceuticals (US) Inc.NDA 218592letter (PDF)Product Qualitydecision 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)Product Qualityn/a
Mar 11, 2025Seikagaku CorporationBLA 761393letter (PDF)Product Quality; Product Quality Microbiologyn/a
Mar 10, 2025Laurus Generics, Inc.NDA 217719letter (PDF)·n/a
Jan 31, 2025SFJ Pharmaceuticals, Inc.BLA 761290letter (PDF)Quality Microbiology; Product Qualityn/a
Jan 17, 2025Hospira, Inc.NDA 219112letter (PDF)Nonclinicaln/a
Jan 15, 2025Atara Biotherapeutics, Inc.BL 125745letter (PDF)Chemistry, Manufacturing, and Controlsn/a
Jan 3, 2025OWP Pharmaceuticals, Inc.NDA 218879letter (PDF)·n/a
Jan 3, 2025Tanvex BioPharma USA, Inc.BLA 761266letter (PDF)Microbiology; Product Qualityn/a

2024 · 69 letters

DateCompanyApplicationLetterSections addressed (from the PDF)On 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)Product Qualityn/a
Dec 13, 2024Janssen Biotech, Inc.BLA 761433letter (PDF)Clinical Pharmacologyn/a
Dec 11, 2024Meitheal Pharmaceuticals Inc.NDA 212271letter (PDF)·n/a
Dec 11, 2024Fresenius Kabi USA, LLCNDA 214610letter (PDF)Product Qualityn/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)Facility Inspectionsn/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)Clinicaln/a
Oct 8, 2024Zealand Pharma US, Inc.NDA 217724/Original 1, NDA 2letter (PDF)·n/a
Oct 7, 2024CSL Behring LLCBLA 761367letter (PDF)Microbiology; Product Quality; Devicen/a
Sep 30, 2024Celltrion Inc.BLA 761338letter (PDF)Product Qualityn/a
Aug 20, 2024Regeneron Pharmaceuticals, Inc.BLA 761400letter (PDF)Facility Inspections; Risk Evaluation and Mitigation Strategy Requirementsn/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)Risk Evaluation and Mitigation Strategy Requirementsn/a
Jul 26, 2024RB Health (US) LLCNDA 217338letter (PDF)Clinicaln/a
Jul 25, 2024Xspray Pharma ABNDA 216195letter (PDF)Product Qualityn/a
Jul 15, 2024Orexo ABNDA 217433letter (PDF)Product Quality; Human Factors; Nonclinicaln/a
Jul 11, 2024MEDRx USA, Inc.NDA 215029letter (PDF)·n/a
Jul 10, 2024Novo Nordisk Inc.BLA 761326letter (PDF)Facility Inspections; Chemistry, Manufacturing, and Controls (CMC); Clinicaln/a
Jul 4, 2024Samsung Bioepis Co., Ltd.BLA 761373/Original 2, BLA 7letter (PDF)·n/a
Jul 1, 2024Amneal EU, Ltd.NDA 218345letter (PDF)Product Quality; Regulatoryn/a
Jun 27, 2024CELLTRION, Inc.BLA 761377letter (PDF)·n/a
Jun 26, 2024Daiichi Sankyo, Inc.BLA 761366letter (PDF)Product Quality; Clinicaln/a
Jun 18, 2024AbbVie Inc.NDA 216962letter (PDF)Facility Inspections; Human Factorsn/a
Jun 14, 2024Rocket Pharmaceuticals, Inc.BL 125806letter (PDF)Chemistry, Manufacturing, and Controlsn/a
Jun 14, 2024Nanocopoeia, LLCNDA 217379letter (PDF)·n/a
Jun 13, 2024Bayer HealthCare LLCNDA 218506letter (PDF)Facility Inspectionsn/a
Jun 12, 2024XTM Consulting LLCNDA 218698letter (PDF)·n/a
May 24, 2024NeuroDerm, Ltd.NDA 218317letter (PDF)Product Quality; Nonclinical; Device; Facility Inspections; Clinical Pharmacology; Human Factorsn/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)Product Quality (Microbiology); Product Quality; Drug Substance; Microbiologyn/a
Apr 19, 2024Xbrane Biopharma ABBLA 761187letter (PDF)·n/a
Apr 17, 2024Accord Healthcare Inc.NDA 218762letter (PDF)no text layer (scanned PDF)n/a
Apr 16, 2024Abeona Therapeutics, Inc.BL 125807letter (PDF)Chemistry, Manufacturing, and Controls (CMC)n/a
Apr 12, 2024Gan & Lee PharmaceuticalsBLA 761356letter (PDF)Facility Inspections; Product Quality; Microbiologyn/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)Facility Inspectionsn/a
Mar 22, 2024Cipla USA, Inc.NDA 210168letter (PDF)·n/a
Mar 22, 2024Regeneron Pharmaceuticals, Inc.BLA 761303/Original 1letter (PDF)Product Qualityn/a
Mar 22, 2024Regeneron Pharmaceuticals, Inc.BLA 761303/Original 2letter (PDF)Product Qualityn/a
Mar 8, 2024Mapi Pharma Ltd.NDA 218223letter (PDF)Microbiology; Clinical/Statistical; Clinical Pharmacology; Nonclinical; Facility Inspectionsn/a
Mar 7, 2024Accord Healthcare Inc.NDA 215749letter (PDF)·n/a
Feb 26, 2024Minerva Neurosciences, IncNDA 217002letter (PDF)Product Quality; Biopharmaceutics; Nonclinical; Clinical Pharmacology; Clinicaln/a
Feb 22, 2024Venatorx Pharmaceuticals, Inc.NDA 217556letter (PDF)Nonclinical; Clinical Pharmacologyn/a
Feb 9, 2024Xeris Pharmaceuticals, Inc.NDA 212097/S-012letter (PDF)Chemistry, Manufacturing and Controlsn/a
Jan 30, 2024Accord Healthcare Inc.NDA 218470letter (PDF)Product Qualityn/a
Jan 25, 2024Defender Pharmaceuticals, IncNDA 214315letter (PDF)Human Factorsn/a
Jan 25, 2024AFT Pharmaceuticals LtdNDA 218528letter (PDF)Microbiologyn/a
Jan 23, 2024Hikma Pharmaceuticals USA, Inc.NDA 218258letter (PDF)Clinical; Product Quality; Facility Inspections; Biopharmaceuticsn/a
Jan 19, 2024Akeso Biopharma Co., Ltd.BLA 761258letter (PDF)Clinical; Facility Inspectionsn/a
Jan 17, 2024BendaRx USA CorporationNDA 215291letter (PDF)·n/a
Jan 12, 2024SQ Innovation, Inc.NDA 217294letter (PDF)Devicen/a
Jan 4, 2024Astellas Pharma US, Inc.BLA 761365letter (PDF)·n/a

2023 · 30 letters

DateCompanyApplicationLetterSections addressed (from the PDF)On this site
Dec 18, 2023CooperSurgical, Inc.NDA 018680/S-074letter (PDF)Facility Inspectionsn/a
Dec 15, 2023Checkpoint Therapeutics, IncorporatedBLA 761297letter (PDF)Facility Inspections; Product Qualityn/a
Oct 11, 2023Alvotech USA Inc.BLA 761343letter (PDF)Facility Inspections; Product Qualityn/a
Sep 29, 2023Galderma R&D, LLCBLA 761311letter (PDF)Product Quality; Microbiologyn/a
Sep 28, 2023Eli Lilly and CompanyBLA 761306letter (PDF)Product Qualityn/a
Sep 22, 2023Botanix SB Inc.NDA 217347letter (PDF)Human Factorsn/a
Sep 19, 2023ARS Pharmaceuticals, Inc.NDA 214697letter (PDF)Product Quality; Devicen/a
Aug 1, 2023Shilpa Medicare LimitedNDA 212782letter (PDF)Facility Inspections; Product Qualityn/a
Aug 1, 2023Mesoblast, Inc.BL 125706letter (PDF)Chemistry, Manufacturing, and Controls; Clinicaln/a
Jul 28, 2023Citius Pharmaceuticals, Inc.BLA 761312letter (PDF)Product Quality; Facility Inspectionsn/a
Jul 27, 2023Laboratorios Farmacéuticos ROVI, S.A.NDA 214835letter (PDF)Facility Inspections; Product Quality; Human Factors; Biopharmaceutics; Facilitiesn/a
Jun 30, 2023Impax Laboratories, LLCNDA 217186letter (PDF)·n/a
Jun 28, 2023Alvotech USA, Inc.BLA 761299letter (PDF)Facility Inspectionsn/a
Jun 27, 2023Regeneron Pharmaceuticals, Inc.BLA 761355letter (PDF)·n/a
May 31, 2023Fresenius Kabi USA, LLCBLA 761275letter (PDF)Facilitiesn/a
May 31, 2023AOP Orphan Pharmaceuticals GmbHNDA 217202letter (PDF)Product Qualityn/a
May 5, 2023Galephar Pharmaceutical Research Inc.NDA 215040letter (PDF)Clinical; Regulatoryn/a
Apr 28, 2023Ascendis Pharma Bone Diseases A/SNDA 216490letter (PDF)·n/a
Apr 24, 2023Novo NordiskBLA 761315letter (PDF)Clinical and Clinical Pharmacology; Device; Product Quality; Facility Inspection; Microbiology; Human Factorsn/a
Apr 12, 2023Hugel, IncBLA 761225letter (PDF)Facility Inspections; Immunogenicityn/a
Mar 30, 2023Eli Lilly and CompanyBLA 761279letter (PDF)Facility Inspections; Microbiologyn/a
Mar 17, 2023AbbVie Inc.NDA 216962letter (PDF)Facility Inspections; Human Factorsn/a
Mar 3, 2023Zydus Worldwide DMCCNDA 211566letter (PDF)·n/a
Feb 14, 2023Tanvex BioPharma USA, Inc.BLA 761126letter (PDF)Facility Inspections; Product Qualityn/a
Feb 7, 2023Phathom Pharmaceuticals, Inc.NDA 215151letter (PDF)·n/a
Jan 20, 2023StemCyte, Inc.BL 125764letter (PDF)Chemistry, Manufacturing, and Controlsn/a
Jan 18, 2023Eli Lilly and CompanyBLA 761248letter (PDF)Product Qualityn/a
Jan 13, 2023Mylan Pharmaceuticals Inc., a Viatris CompanNDA 204311letter (PDF)Facility Inspectionsn/a
Jan 13, 2023Almatica Pharma, LLCNDA 215721letter (PDF)Product Qualityn/a
Jan 6, 2023Liqmeds Worldwide LimitedNDA 216482letter (PDF)Risk Evaluation and Mitigation Strategy Requirementsn/a

2022 · 24 letters

DateCompanyApplicationLetterSections addressed (from the PDF)On this site
Dec 23, 2022lpsen Biopharmaceuticals Inc.NDA 215559letter (PDF)·n/a
Dec 20, 2022Alvotech USA, Inc.BLA 761299letter (PDF)Facility Inspectionsn/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)Product Qualityn/a
Jul 15, 2022Laboratorios Farmaceuticos Rovi, S.A.NDA 214835letter (PDF)Facility Inspections; Product Quality; Human Factors; Biopharmaceutics; Facilitiesn/a
Jun 30, 2022AFT Pharmaceuticals Ltd.NDA 215320letter (PDF)Nonclinicaln/a
Jun 15, 2022Acer Therapeutics Inc.NDA 214860letter (PDF)Facility Inspection; Nonclinicaln/a
Jun 6, 2022Braintree Laboratories, Inc.NDA 215344letter (PDF)·n/a
May 23, 2022Verrica Pharmaceuticals Inc.NDA 212905letter (PDF)Product Quality; Human Factorsn/a
May 12, 2022UGB, Inc.BLA 761151letter (PDF)Product Quality; Facility Inspectionsn/a
Apr 29, 2022Coherus BioSciences, Inc.BLA 761240letter (PDF)Product Qualityn/a
Apr 28, 2022CMP Development LLCNDA 214952letter (PDF)Facility Inspections; Product Qualityn/a
Apr 18, 2022Dr. Reddy’s Laboratories LimitedNDA 210852letter (PDF)Facility Inspectionsn/a
Apr 15, 2022Teva Neuroscience, Inc.NDA 213586letter (PDF)Clinicaln/a
Apr 14, 2022Shilpa Medicare LimitedNDA 215179letter (PDF)Product Quality; Facility Inspectionsn/a
Mar 31, 2022Hugel, IncBLA 761225letter (PDF)Facility Inspections; Immunogenicityn/a
Mar 29, 2022Akebia Therapeutics, Inc.NDA 215192letter (PDF)Clinical and Statisticaln/a
Feb 28, 2022Gilead Sciences, Inc.NDA 215973letter (PDF)Product Quality; Clinicaln/a
Feb 26, 2022Amryt Pharmaceuticals DACNDA 215064letter (PDF)Clinicaln/a
Feb 25, 2022Green Cross CorporationBL 125743letter (PDF)Chemistry, Manufacturing, and Controlsn/a
Feb 18, 2022Shandong Luye Pharmaceutical Co., Ltd.NDA 212849letter (PDF)Clinical and Clinical Pharmacology; Product Quality; Facility Inspectionsn/a
Feb 18, 2022Mallinckrodt Pharmaceuticals Ireland LtdNDA 022231letter (PDF)Clinical; Clinical/Statistical; Facility Inspectionsn/a
Jan 21, 2022Pfizer Ireland PharmaceuticalsBLA 761184letter (PDF)Product Quality; Facility Inspectionsn/a

2021 · 48 letters

DateCompanyApplicationLetterSections addressed (from the PDF)On this site
Dec 22, 2021Therakind LimitedNDA 212479letter (PDF)Product Qualityn/a
Dec 17, 2021Eli Lilly and CompanyBLA 761215/Original 2, BLA 7letter (PDF)Regulatoryn/a
Dec 17, 2021Takeda Pharmaceuticals U.S.A., Inc.NDA 213976letter (PDF)·n/a
Dec 17, 2021Eli Lilly and CompanyBLA 761215/Original 2, BLA 7letter (PDF)Regulatoryn/a
Dec 15, 2021Braeburn Inc.NDA 210136letter (PDF)Facility Inspections; Risk Evaluation and Mitigation Strategy Requirements; Microbiologyn/a
Nov 26, 2021Fennec Pharmaceuticals, Inc.NDA 212937letter (PDF)Product Qualityn/a
Nov 24, 2021Celitrion, Inc.BLA 761219letter (PDF)·n/a
Nov 19, 2021Bio-Thera Solutions Ltd.BLA 761198letter (PDF)Clinical Pharmacology; Microbiology; Product Quality; Facility Inspectionsn/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)Facility Inspectionsn/a
Oct 15, 2021Omeros CorporationBLA 761152letter (PDF)Clinical and Statistical; Product Qualityn/a
Oct 14, 2021Revance Therapeutics, Inc.BLA 761127letter (PDF)Product Qualityn/a
Oct 5, 2021Polarean Inc.NDA 214375letter (PDF)Product Quality; Facility Inspectionsn/a
Sep 24, 2021Laboratorios Farmaceuticos Rovi, S.A.NDA 214835letter (PDF)Facility Inspections; Product Quality; Human Factors; Biopharmaceutics; Facilitiesn/a
Sep 16, 2021Verrica Pharmaceuticals Inc.NDA 212905letter (PDF)Product Quality; Human Factorsn/a
Sep 14, 2021HQ Specialty Pharma CorporationNDA 215212letter (PDF)Nonclinical; Product Quality; Clinical; Clinical Microbiologyn/a
Sep 2, 2021Zydus Worldwide DMCCNDA 211566letter (PDF)·n/a
Aug 25, 2021Zhejiang Novus Pharmaceuticals Co. Ltd.NDA 210274letter (PDF)Facility Inspections; Product Qualityn/a
Aug 18, 2021CellTrans Inc.BL 125734letter (PDF)Chemistry, Manufacturing, and Controlsn/a
Aug 11, 2021Kashiv BioSciences, LLCBLA 761084letter (PDF)Microbiology; Facility Inspections; Immunogenicityn/a
Aug 5, 2021LLCNDA 214952letter (PDF)Facility Inspections; Product Qualityn/a
Aug 3, 2021Spectrum Pharmaceuticals, Inc.BLA 761148letter (PDF)Product Quality; Facility Inspectionsn/a
Aug 2, 2021Kashiv BioSciences, LLCBLA 761082letter (PDF)Facility Inspections; Product Quality; Product Quality Microbiologyn/a
Jul 30, 2021medac Gesellschaft fur klinische SpezialprapNDA 214759letter (PDF)Clinical/Statistical; Nonclinicaln/a
Jul 28, 2021Ardelyx, Inc.NDA 213931letter (PDF)Clinicaln/a
Jul 23, 2021lterum Therapeutics U.S. Ltd.NDA 213972letter (PDF)CLINICAL and STATISTICALn/a
Jul 2, 2021Provention Bio, Inc.BLA 761183letter (PDF)Clinical Pharmacology; Facility Inspections; Clinical; Product Qualityn/a
Jun 25, 2021Cyclomedica Australia Pty Ltd.NDA 022335letter (PDF)Product Quality; Facility Inspectionsn/a
Jun 25, 2021MediWound, Ltd.BLA 761192letter (PDF)Product Quality; Clinical Pharmacologyn/a
Jun 24, 2021Shilpa Medicare LimitedNDA 215179letter (PDF)Product Quality; Facility Inspectionsn/a
Jun 17, 2021Orphazyme A/SNDA 214927letter (PDF)·n/a
Jun 14, 2021Nevakar, Inc.NDA 214628letter (PDF)Facility Inspectionsn/a
May 28, 2021Azurity Pharmaceuticals, Inc.NDA 214273letter (PDF)Facility Inspectionsn/a
May 20, 2021Tanvex BioPharma USA, Inc.BLA 761126letter (PDF)Facility Inspections; Product Qualityn/a
Apr 30, 2021Accord Healthcare, Inc.NDA 215000letter (PDF)Product Qualityn/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)Facility Inspectionsn/a
Mar 12, 2021PharmaEssentia CorporationBLA 761166letter (PDF)Human Factors; Facility Inspectionsn/a
Feb 26, 2021CorMedix Inc.NDA 214520letter (PDF)Product Qualityn/a
Feb 23, 2021CMP Development LLCNDA 214522letter (PDF)·n/a
Feb 12, 2021Novitium Pharma LLCNDA 214581letter (PDF)Drug Product Qualityn/a
Jan 28, 2021Azurity Pharmaceuticals, Inc.NDA 213593letter (PDF)Product Quality; Clinicaln/a
Jan 21, 2021Emory Partners, LLCNDA 210526letter (PDF)Facility Inspections; Regulatoryn/a
Jan 8, 2021HQ Specialty Pharma CorporationNDA 211413letter (PDF)Nonclinicaln/a

2020 · 36 letters

DateCompanyApplicationLetterSections addressed (from the PDF)On this site
Dec 22, 2020Kashiv BioSciences, LLCBLA 761082letter (PDF)Facility Inspections; Product Quality; Product Quality Microbiologyn/a
Dec 22, 2020InnoPharma Licensing LLCNDA 206968letter (PDF)Nonclinical; Facility Inspections; Regulatory; Product Qualityn/a
Dec 18, 2020Novartis Pharmaceuticals CorporationNDA 214012letter (PDF)Facility Inspectionsn/a
Dec 3, 2020scPharmaceuticals Services, IncNDA 209988letter (PDF)Device; Human Factors; Facility Inspections; Drug Product Quality; Clinicaln/a
Dec 1, 2020Braeburn Inc.NDA 210136letter (PDF)Facility Inspections; Risk Evaluation and Mitigation Strategy Requirements; Microbiologyn/a
Nov 27, 2020Zhejiang Novus Pharmaceuticals Co. Ltd.NDA 210274letter (PDF)Facility Inspections; Product Qualityn/a
Nov 23, 2020Genentech, IncorporatedNDA 214410/Original 2, NDA 2letter (PDF)·n/a
Nov 13, 2020Adamis Pharmaceuticals CorporationNDA 212854letter (PDF)Clinical; Product Quality; Devices; Nonclinical; Clinical Pharmacologyn/a
Nov 13, 2020Bioverativ USA, Inc.BLA 761164letter (PDF)Facility Inspectionsn/a
Nov 13, 2020Alkermes, Inc.NDA 213378/Original 1, NDA 2letter (PDF)Product Quality; Facility Inspectionsn/a
Nov 12, 2020sanofi-aventis U.S. LLCNDA 214429letter (PDF)·n/a
Nov 6, 2020AFT Pharmaceuticals, Inc.NDA 209471letter (PDF)Clinical; Statistical; Nonclinical; Product Quality; Facility Inspectionsn/a
Nov 6, 2020Dr. Reddy’s Laboratories LimitedNDA 210852letter (PDF)Facility Inspectionsn/a
Nov 6, 2020Supernus Pharmaceuticals, Inc.NDA 211964letter (PDF)Facility Inspectionsn/a
Oct 16, 2020CMP Development LLCNDA 213260letter (PDF)·n/a
Sep 11, 2020Mallinckrodt Hospital Products IP LimitedNDA 022231letter (PDF)Clinical; Clinical/Statistical; Facility Inspectionsn/a
Aug 13, 2020Nobelpharma Co., Ltd.NDA 213478letter (PDF)Facility Inspectionsn/a
Aug 10, 2020Fennec Pharmaceuticals, Inc.NDA 212937letter (PDF)Product Qualityn/a
Aug 3, 2020DBV Technologies S.A.BL 125713letter (PDF)Clinical; CHEMISTRY, MANUFACTURING, and CONTROLS; Manufacturing and Product Qualityn/a
Jul 23, 2020Corium, Inc.NDA 212304letter (PDF)·n/a
Jul 13, 2020Verrica Pharmaceuticals Inc.NDA 212905letter (PDF)Product Quality; Human Factorsn/a
Jun 26, 2020Heron Therapeutics, Inc.NDA 211988letter (PDF)Nonclinicaln/a
Jun 15, 2020Esteve Pharmaceuticals, S.A.NDA 213426letter (PDF)Facility Inspections; Risk Evaluation and Mitigation Strategy Requirementsn/a
May 26, 2020Althera Life Sciences, LLCNDA 213072letter (PDF)Product Quality; Facility Inspections; Clinicaln/a
May 21, 2020Dr. Reddy’s Laboratories LimitedNDA 210852letter (PDF)Facility Inspectionsn/a
May 18, 2020Par Sterile Products, LLCNDA 212156letter (PDF)Product Quality; Nonclinical; Facility Inspectionsn/a
Apr 24, 2020B. Braun Medical, Inc.NDA 204957letter (PDF)Facility Inspections; Regulatoryn/a
Mar 24, 2020IntelGenx Corp.NDA 205394letter (PDF)Facility Inspections; Product Quality; Clinicaln/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)Facility Inspections; Product Qualityn/a
Feb 28, 2020Hikma Pharmaceuticals USA Inc.NDA 212045letter (PDF)Product Quality; Nonclinical; Human Factorsn/a
Jan 28, 2020Shandong Luye Pharmaceutical Co., Ltd.NDA 212849letter (PDF)Clinical and Clinical Pharmacology; Product Quality; Facility Inspectionsn/a
Jan 28, 2020Recordati Rare Diseases Inc.NDA 211302letter (PDF)·n/a
Jan 14, 2020Ingenus Pharmaceuticals, LLCNDA 212501letter (PDF)Facility Inspectionsn/a
Jan 10, 2020Sarfez Pharmaceuticals Inc.NDA 213218letter (PDF)·n/a

2019 · 36 letters

DateCompanyApplicationLetterSections addressed (from the PDF)On this site
Dec 26, 2019HQ Specialty Pharma CorporationNDA 211413letter (PDF)Nonclinicaln/a
Dec 20, 2019Sedor Pharmaceuticals, LLCNDA 210864letter (PDF)Product Quality; Clinicaln/a
Dec 19, 2019ViiV Healthcare CompanyNDA 212888letter (PDF)Product Qualityn/a
Dec 17, 2019Takeda Pharmaceuticals, U.S.A., Inc.BLA 761133letter (PDF)Product Quality; Human Factors; Facility Inspections; Microbiology; Clinical Pharmacologyn/a
Nov 22, 2019Adamis Pharmaceuticals CorporationNDA 212854letter (PDF)Clinical; Product Quality; Devices; Nonclinical; Clinical Pharmacologyn/a
Nov 20, 2019Dr. Reddy’s Laboratories LimitedNDA 210852letter (PDF)Facility Inspectionsn/a
Nov 4, 2019CLASS 2 RESUBMISSIONNDA 208574letter (PDF)Product Quality; Facility Inspectionsn/a
Oct 18, 2019Clearside Biomedical, Inc.NDA 211950letter (PDF)·n/a
Oct 1, 2019AuroMedics Pharma LLCNDA 210735letter (PDF)Facility Inspectionsn/a
Sep 30, 2019AstraZeneca ABNDA 212122letter (PDF)·n/a
Sep 24, 2019Tanvex BioPharma USA, Inc.BLA 761126letter (PDF)Facility Inspections; Product Qualityn/a
Aug 28, 2019Mylan GmbHNDA 210605letter (PDF)Product Qualityn/a
Aug 19, 2019Sarepta Therapeutics, Inc.NDA 211970letter (PDF)Clinicaln/a
Aug 14, 2019Bioprojet PharmaNDA 211150/Original 2, NDA 2letter (PDF)Clinicaln/a
Aug 7, 2019Kala Pharmaceuticals, Inc.NDA 210933letter (PDF)no text layer (scanned PDF)n/a
Aug 6, 2019Mylan Pharmaceuticals Inc.NDA 204311letter (PDF)Facility Inspectionsn/a
Jul 19, 2019Bausch Health Ireland LimitedNDA 211039letter (PDF)·n/a
Jul 18, 2019Ricon Pharma, LLCNDA 212501letter (PDF)Facility Inspectionsn/a
Jun 20, 2019Glenmark Pharmaceuticals, Inc.NDA 211746letter (PDF)Facility Inspections; Product Qualityn/a
Jun 19, 2019Chiesi USA, Inc.NDA 202049letter (PDF)Clinicaln/a
Jun 11, 2019Kashiv BioSciences, LLCBLA 761082letter (PDF)Facility Inspections; Product Quality; Product Quality Microbiologyn/a
Jun 6, 2019Mylan Laboratories LimitedNDA 206610letter (PDF)Facility Inspections; Regulatory; Nonclinicaln/a
May 3, 2019Dr. Reddy’s Laboratories, IncNDA 210852letter (PDF)Facility Inspectionsn/a
May 2, 2019Acacia Pharma LtdNDA 209510letter (PDF)·n/a
Apr 30, 2019Heron Therapeutics, Inc.NDA 211988letter (PDF)Nonclinicaln/a
Apr 1, 2019Evoke Pharma, Inc.NDA 209388letter (PDF)Clinical Pharmacologyn/a
Mar 29, 2019Proximagen, LLCNDA 211321letter (PDF)Facility Inspectionsn/a
Mar 28, 2019IntelGenx Corp.NDA 205394letter (PDF)Facility Inspections; Product Quality; Clinicaln/a
Mar 28, 2019Fera Pharmaceuticals, LLCNDA 202408letter (PDF)·n/a
Mar 27, 2019B. Braun Medical, Inc.NDA 204957letter (PDF)Facility Inspections; Regulatoryn/a
Mar 22, 2019Recro Pharma Inc.NDA 210583letter (PDF)Clinical; Nonclinical; Product Qualityn/a
Mar 22, 2019Sedor Pharmaceuticals, LLCNDA 210864letter (PDF)Product Quality; Clinicaln/a
Jan 29, 2019Sunovion Pharmaceuticals Inc.NDA 210875letter (PDF)Clinical Pharmacology and Biopharmaceuticsn/a
Jan 23, 2019Vero Biotech, LLCNDA 202860letter (PDF)Facility Inspections; Human Factors; Regulatoryn/a
Jan 17, 2019Immunomedics, IncBLA 761115letter (PDF)Product Quality; Facility Inspections; Immunogenicity; Product Quality Microbiologyn/a
Jan 15, 2019AuroMedics Pharma LLCNDA 210735letter (PDF)Facility Inspectionsn/a

2018 · 33 letters

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

2017 · 25 letters

DateCompanyApplicationLetterSections addressed (from the PDF)On this site
Dec 22, 2017AFT Pharmaceuticals, Ltd.NDA 209471letter (PDF)Clinical; Statistical; Nonclinical; Product Quality; Facility Inspectionsn/a
Dec 21, 2017Agile Therapeutics, Inc.NDA 204017letter (PDF)Product Quality; Facility Inspections; Clinical; Chemistry, Manufacturing and Controls (CMC); Biopharmaceutics; Clinical Pharmacologyn/a
Dec 6, 2017Mylan Laboratories LimitedNDA 206610letter (PDF)Facility Inspections; Regulatory; Nonclinicaln/a
Nov 3, 2017Hospira, Inc.NDA 209191letter (PDF)Product Quality; Facility Inspectionsn/a
Oct 26, 2017Teva Pharmaceuticals USA, Inc.NDA 210063letter (PDF)Nonclinical; Product Quality; Devicen/a
Oct 20, 2017Antares Pharma, Inc.NDA 209863letter (PDF)Clinicaln/a
Oct 11, 2017AcelRx Pharmaceuticals, Inc.NDA 209128letter (PDF)Human Factors; Risk Evaluation and Mitigation Strategy Requirementsn/a
Sep 28, 2017B. Braun Medical, Inc.NDA 204957letter (PDF)Facility Inspections; Regulatoryn/a
Sep 26, 2017Actavis, L.L.C.NDA 208419letter (PDF)Chemistry, Manufacturing, and Controlsn/a
Sep 1, 20173M Health Care (Infection Prevention DivisioNDA 208288letter (PDF)Nonclinical; Chemistry, Manufacturing and Controls; Clinical; Clinical Pharmacology; Product Quality; Microbiologyn/a
Aug 28, 2017Astellas Pharma US, Inc.NDA 209529letter (PDF)Facility Inspectionsn/a
Jul 28, 2017Ironshore Pharmaceuticals & Development, IncNDA 209311letter (PDF)Clinicaln/a
Jul 13, 2017Amgen Inc.BLA 761062letter (PDF)·n/a
Jul 10, 2017Ocular Therapeutix, Inc.NDA 208742letter (PDF)Facilities Inspectionn/a
Jun 9, 2017Coherus BioSciences, Inc.BLA 761039letter (PDF)Immunogenicity; Product Qualityn/a
Jun 2, 2017United Therapeutics CorporationNDA 208276letter (PDF)Clinical; Product Qualityn/a
Jun 2, 2017Teva Pharmaceuticals USA Inc.NDA 208574letter (PDF)Product Quality; Facility Inspectionsn/a
May 23, 2017Sun Pharmaceutical Industries LimitedNDA 208313letter (PDF)Facility Inspectionsn/a
May 5, 2017TherapeuticsMD, Inc.NDA 208564letter (PDF)Clinical Safety; Chemistry, Manufacturing, and Controlsn/a
Apr 26, 2017Hospira, Inc.NDA 209191letter (PDF)Product Quality; Facility Inspectionsn/a
Mar 24, 2017Institut Biochimique SA (IBSA)NDA 206976letter (PDF)Biopharmaceuticsn/a
Mar 22, 2017Sun Pharma Advanced Research Company LimitedNDA 204417letter (PDF)Facility Inspections; Regulatory Information; Clinical Pharmacologyn/a
Feb 17, 2017Amphastar Pharmaceuticals, Inc.NDA 208969letter (PDF)Facility Inspectionsn/a
Feb 1, 2017Mylan Laboratories LimitedNDA 206610letter (PDF)Facility Inspections; Regulatory; Nonclinicaln/a
Jan 11, 2017Metacel Pharmaceuticals, LLCNDA 208193letter (PDF)Product Quality; Nonclinicaln/a

2016 · 20 letters

DateCompanyApplicationLetterSections addressed (from the PDF)On this site
Dec 23, 2016Armstrong Pharmaceuticals, Inc.NDA 205920letter (PDF)Clinical; Product Quality; Nonclinicaln/a
Dec 19, 2016Sun Pharma Advanced Research Company LimitedNDA 206185letter (PDF)Facility Inspections; Product Qualityn/a
Nov 23, 2016Ferring Pharmaceuticals, Inc.NDA 201110letter (PDF)Device; Clinical; Product Quality; Facility Inspections; Microbiologyn/a
Nov 15, 2016InnoPharma Licensing LLCNDA 206968letter (PDF)Nonclinical; Facility Inspections; Regulatory; Product Qualityn/a
Oct 7, 2016United Therapeutics CorporationNDA 208276letter (PDF)Clinical; Product Qualityn/a
Sep 30, 2016Teva Pharmaceuticals USANDA 208042letter (PDF)Facility Inspections; Risk Evaluation and Mitigation Strategy Requirementsn/a
Sep 15, 2016The Feinstein Institute for Medical ResearchNDA 200655letter (PDF)Product Qualityn/a
Aug 30, 2016Dr. Reddy’s Laboratories, SANDA 206966letter (PDF)Facility Inspectionsn/a
Jul 21, 2016Ocular Therapeutix, Inc.NDA 208742letter (PDF)Facilities Inspectionn/a
Jun 24, 2016Fera Pharmaceuticals, LLCNDA 202408letter (PDF)·n/a
Jun 24, 2016Sandoz Inc.BLA 761045letter (PDF)Clinical Pharmacology; Product Qualityn/a
Jun 22, 2016Salamandra, LLCNDA 208647letter (PDF)Facility Inspectionsn/a
Jun 1, 2016Teva Pharmaceuticals USANDA 208574letter (PDF)Product Quality; Facility Inspectionsn/a
May 27, 2016Teva Pharmaceuticals, Inc.NDA 208082letter (PDF)Clinical Pharmacology; Nonclinical; Product Qualityn/a
May 10, 2016Scilex Pharmaceuticals, Inc.NDA 207962letter (PDF)Regulatory; Clinical; Clinical Pharmacology; Nonclinical; Product Quality; Biopharmaceutics; Facility Inspectionsn/a
May 6, 20163M Health Care (Infection Prevention DivisioNDA 208288letter (PDF)Nonclinical; Chemistry, Manufacturing and Controls; Clinical; Clinical Pharmacology; Product Quality; Microbiologyn/a
May 4, 2016Dr. Reddy’s Laboratories, Limited-NDA 206927/Original 1, NDA 2letter (PDF)Product Quality; Facility Inspectionsn/a
Apr 28, 2016Evofem, Inc.NDA 208352letter (PDF)Clinical; Facility Inspectionsn/a
Apr 15, 2016Camargo Pharmaceutical ServicesNDA 208232letter (PDF)·n/a
Mar 10, 2016Mylan Laboratories LimitedNDA 206610letter (PDF)Facility Inspections; Regulatory; Nonclinicaln/a

2015 · 9 letters

DateCompanyApplicationLetterSections addressed (from the PDF)On this site
Dec 9, 2015Belcher Pharmaceuticals, LLC.NDA 207987letter (PDF)Clinical; Product Quality; Facility Inspectionsn/a
Nov 24, 2015Sun Pharmaceutical Industries LimitedNDA 208313letter (PDF)Facility Inspectionsn/a
Sep 23, 2015Sun Pharma Advanced Research Company LimitedNDA 204417letter (PDF)Facility Inspections; Regulatory Information; Clinical Pharmacologyn/a
Aug 27, 2015Amgen, Inc.BLA 125522letter (PDF)Clinicaln/a
Jul 30, 2015Sun Pharma Advanced Research Company LimitedNDA 206185letter (PDF)Facility Inspections; Product Qualityn/a
May 29, 2015ELC GroupNDA 205054letter (PDF)Clinical/Statistical; Product Quality; Regulatory; Facility Inspectionsn/a
Feb 27, 2015Mylan Pharmaceuticals, Inc.NDA 206610letter (PDF)Facility Inspections; Regulatory; Nonclinicaln/a
Feb 27, 2015nnoPharma Licensing LLCNDA 206968letter (PDF)Nonclinical; Facility Inspections; Regulatory; Product Qualityn/a
Jan 30, 2015Ferring Pharmaceuticals Inc.NDA 022517letter (PDF)Clinical/Statistical; Clinical Pharmacology; Nonclinicaln/a

2014 · 8 letters

DateCompanyApplicationLetterSections addressed (from the PDF)On this site
Dec 17, 2014Dr. Reddy’s Laboratories, Limited-NDA 206927/Original 1, NDA 2letter (PDF)Product Quality; Facility Inspectionsn/a
Nov 24, 2014Sun Pharma Advanced Research Company LimitedNDA 206185letter (PDF)Facility Inspections; Product Qualityn/a
Nov 3, 2014Clarus Therapeutics, Inc.NDA 206089letter (PDF)·n/a
Oct 23, 2014Mylan Pharmaceuticals Inc.NDA 204311letter (PDF)Facility Inspectionsn/a
May 22, 2014Armstrong PharmaceuticalsNDA 205920letter (PDF)Clinical; Product Quality; Nonclinicaln/a
Mar 31, 2014Fera Pharmaceuticals, LLCNDA 202408letter (PDF)·n/a
Feb 12, 2014DURECT CorporationNDA 204803letter (PDF)Clinicaln/a
Jan 31, 2014RedHill Biopharma Ltd.NDA 205394letter (PDF)Facility Inspections; Product Quality; Clinicaln/a

2013 · 12 letters

DateCompanyApplicationLetterSections addressed (from the PDF)On this site
Nov 4, 2013NorthStar Medical Radioisotopes, LLCNDA 202158letter (PDF)Clinical; Product Quality Microbiology; Facility Inspectionsn/a
Oct 22, 2013Thomas Chaly, Ph.D., FAICNDA 200655letter (PDF)Product Qualityn/a
Sep 12, 2013Delcath Systems, IncorporatedNDA 201848letter (PDF)Clinical; Clinical Pharmacology; Facility inspectionsn/a
Jul 17, 2013Agile Therapeutics, Inc.NDA 204017letter (PDF)Product Quality; Facility Inspections; Clinical; Chemistry, Manufacturing and Controls (CMC); Biopharmaceutics; Clinical Pharmacologyn/a
Jun 28, 2013Merck & Co., Inc.NDA 204569letter (PDF)·n/a
Jun 28, 2013GeNO LLCNDA 202860letter (PDF)Facility Inspections; Human Factors; Regulatoryn/a
Jun 6, 2013AVEO Pharmaceuticals, Inc.NDA 204408letter (PDF)Clinical; Product Qualityn/a
May 3, 2013Roxane Laboratories, Inc.NDA 203856letter (PDF)Product Qualityn/a
Mar 29, 2013Sun Pharma Global FZENDA 204417letter (PDF)Facility Inspections; Regulatory Information; Clinical Pharmacologyn/a
Mar 18, 2013Pharmaxis Ltd.NDA 202049letter (PDF)Clinicaln/a
Feb 13, 2013Agile Therapeutics, Inc.NDA 204017letter (PDF)Product Quality; Facility Inspections; Clinical; Chemistry, Manufacturing and Controls (CMC); Biopharmaceutics; Clinical Pharmacologyn/a
Jan 30, 2013Ferring Pharmaceuticals Inc.NDA 022517letter (PDF)Clinical/Statistical; Clinical Pharmacology; Nonclinicaln/a

2012 · 4 letters

DateCompanyApplicationLetterSections addressed (from the PDF)On this site
Jul 26, 2012Otsuka Pharmaceutical Company, Ltd.NDA 202971letter (PDF)Facility Inspectionsn/a
May 18, 2012GeNO LLCNDA 202860letter (PDF)Facility Inspections; Human Factors; Regulatoryn/a
Mar 28, 2012Chelsea Therapeutics, Inc.NDA 203202letter (PDF)Risk Evaluation and Mitigation Strategy Requirements; Product Quality; Clinical Pharmacologyn/a
Jan 17, 2012Bristol-Myers SquibbNDA 202293letter (PDF)Clinicaln/a

2011 · 2 letters

DateCompanyApplicationLetterSections addressed (from the PDF)On this site
Feb 28, 2011Teva Women’s Health, Inc.NDA 201110letter (PDF)Device; Clinical; Product Quality; Facility Inspections; Microbiologyn/a
Feb 28, 2011EMD Serono, Inc.NDA 022561letter (PDF)Clinical; Product Qualityn/a

2010 · 2 letters

DateCompanyApplicationLetterSections addressed (from the PDF)On this site
Apr 22, 2010Ferring Pharmaceuticals Inc.NDA 022517letter (PDF)Clinical/Statistical; Clinical Pharmacology; Nonclinicaln/a
Feb 10, 2010Cadence PharmaceuticalsNDA 022450letter (PDF)Facility Inspectionsn/a

2009 · 2 letters

DateCompanyApplicationLetterSections addressed (from the PDF)On this site
Nov 4, 2009Orphan Therapeutics, LLCNDA 022231letter (PDF)Clinical; Clinical/Statistical; Facility Inspectionsn/a
May 15, 2009King Pharmaceuticals, Inc.NDA 022377letter (PDF)·n/a

2008 · 1 letter

DateCompanyApplicationLetterSections addressed (from the PDF)On this site
Feb 25, 2008Kyowa Pharmaceutical, Inc.NDA 022075letter (PDF)Clinical; Clinical Pharmacology; Nonclinicaln/a

2007 · 1 letter

DateCompanyApplicationLetterSections addressed (from the PDF)On this site
Nov 2, 2007Fabre-Kramer Pharmaceuticals, Inc.NDA 021164letter (PDF)Chemistry, Manufacturing, and Controls; Clinical Pharmacology and Biopharmaceuticsn/a

2004 · 1 letter

DateCompanyApplicationLetterSections addressed (from the PDF)On this site
Jun 23, 2004Organon, Inc.NDA 021164letter (PDF)Chemistry, Manufacturing, and Controls; Clinical Pharmacology and Biopharmaceuticsn/a

2002 · 1 letter

DateCompanyApplicationLetterSections addressed (from the PDF)On this site
Mar 15, 2002Organon, Inc.NDA 021164letter (PDF)Chemistry, Manufacturing, and Controls; Clinical Pharmacology and Biopharmaceuticsn/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. Of the 458 letters the FDA has released, 309 were issued to applications the FDA has since approved.

How many FDA Complete Response Letters are published here?
458 records in the FDA's release (openFDA transparency/crl, last updated 2026-08-26): 455 distinct letters with a hosted PDF are listed, 2 records repeat another verbatim and 1 is still marked under review for release. 160 of the listed letters were issued in 2024 or later; the rest go back to 2002.

How many CRLs are later approved?
This corpus cannot say. openFDA labels 309 of the 458 released letters as belonging to applications the FDA has since approved and 149 as not approved, but the split follows the FDA's release policy, not the odds: the agency released archived letters only for applications it had approved, then every letter from 2024 on. Nearly every letter dated 2023 or earlier is on an approved application and nearly every letter from 2025 on is not. Counts are stated here; a rate from this data would measure what the FDA chose to publish.

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

About · Corrections · Methodology

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