Complete response letters
FDA's letters telling drug and biologic applicants why an application was not approved as submitted. 458 records; openFDA updated it 2026-10-05. About this dataset
Newest records
- Approved309
- Unapproved149
- Ocuvex Therapeutics, Inc. · NDA 217363
yy U.S. FOOD & DRUG ADMINISTRATION NDA 217363 COMPLETE RESPONSE Ocuvex Therapeutics, Inc. Attention: Anthony Amato Chief Executive Officer 1 Bridge Plaza, Second Floor Fort Lee, NJ 07024 Dear Anthony…
- Swedish Orphan Biovitrum AB (publ) · BLA 761438
g U.S. FOOD & DRUG x ADMINISTRATION BLA 761438 COMPLETE RESPONSE Swedish Orphan Biovitrum AB (publ) Attention: Bao Le US Regulatory Lead, Immunology 77 4th Avenue, 3 Floor Waltham, MA 02451 Dear Bao…
- ITM Solucin GmbH · NDA 218705
g U.S. FOOD & DRUG Naty ADMINISTRATION NDA 218705 COMPLETE RESPONSE ITM Solucin GmbH c/o Lumara Bio USA Inc. Attention: Tinya Sow, MHA US Agent, Director - US, Regulatory Lead 5 Vaughn Drive, Suite 3…
- Cingulate Therapeutics, LLC · NDA 220283
g U.S. FOOD & DRUG Naty ADMINISTRATION NDA 220283 COMPLETE RESPONSE Cingulate Therapeutics, LLC Attention: Kelly R. Koehn Vice President, Clinical and Regulatory Operations 1901 W. 47" Place Westwood…
- Disc Medicine, Inc. · NDA 220707
PN U.S. FOOD & DRUG ADMINISTRATION NDA 220707 COMPLETE RESPONSE Disc Medicine, Inc. Attention: Steve Caffé, MD Chief Regulatory Officer 321 Arsenal Street, Suite 101 Watertown, MA 02472 Dear Dr. Caff…
- Fresenius Kabi USA, LLC · NDA 214610
U.S. FOOD & DRUG Sy ADMINISTRATION NDA 214610 COMPLETE RESPONSE Fresenius Kabi USA, LLC Attention: Jennifer Gross, M.S. Senior Regulatory Affairs Associate Three Corporate Drive Lake Zurich, IL 60047…
- REGENXBIO, Inc. · BL 125840
g YN U.S. FOOD & DRUG ADMINISTRATION Our STN: BL 125840/0 COMPLETE RESPONSE February 7, 2026 REGENXBIO, Inc. Attention: Steve Pakola, MD 9804 Medical Center Drive Rockville, MD 20850 Dear Dr. Pakola:…
- Replimune, Inc. · BL 125827
i Lk Fy" U.S. FOOD & DRUG ADMINISTRATION Our STN: BL 125827 COMPLETE RESPONSE APRIL 10, 2026 Replimune, Inc. Attention: Kari Jeschke 500 Unicorn Park Drive Woburn, MA 01801 Dear Kari Jeschke: Please…
- Xspray Pharma AB · NDA 217644
yy U.S. FOOD & DRUG ADMINISTRATION NDA 217644 COMPLETE RESPONSE Xspray Pharma AB c/o Lachman Consultant Services, Inc. Attention: Jennifer Leaming Principal Consultant 1600 Stewart Avenue, Suite 604…
- Ipsen Biopharm Ltd. · BLA 761311
nN U.S. FOOD & DRUG ADMINISTRATION BLA 761311 COMPLETE RESPONSE Ipsen Biopharm Ltd. C/O Galderma Research and Development, Inc. Attention: Chase Edwards Director, Regulatory Affairs 2001 Ross Ave Sui…
- Elevar Therapeutics Inc. · NDA 216586
i Lk YN U.S. FOOD & DRUG ADMINISTRATION NDA 216586 COMPLETE RESPONSE Elevar Therapeutics Inc. ATTENTION: Young-Sil (Anna) Yim Executive Director, Regulatory Affairs: 1 Bridge Plaza North, Suite 850 F…
- Corcept Therapeutics · NDA 219398
IN U.S. FOOD & DRUG ADMINISTRATION NDA 219398 CORRECTED COMPLETE RESPONSE Corcept Therapeutics Attention: Christopher Golis Vice President, Quality Assurance & Regulatory Affairs 101 Redwood Shores P…
- Biogen, Inc. · NDA 209531/S-016
BN U.S. FOOD & DRUG ADMINISTRATION NDA 209531/S-016 COMPLETE RESPONSE Biogen, Inc. Attention: Charlene Wheeler, MSHS Director, Global Regulatory Sciences 225 Binney Street Cambridge, MA 02142 Dear Ch…
- Biohaven Therapeutics, Ltd. · NDA 210862
ADMINISTRATION ¢ Fy U.S. FOOD & DRUG NDA 210862 COMPLETE RESPONSE Biohaven Therapeutics, Ltd. c/o Biohaven Pharmaceuticals, Inc. Attention: Marianne Frost, MA Senior VP, Regulatory Affairs and Operat…
- Accord Healthcare Inc. · NDA 216987
ADMINISTRATION i Lk YN U.S. FOOD & DRUG NDA 216987 COMPLETE RESPONSE Accord Healthcare Inc. Attention: Sabita Nair, RAC, ASQ-CPGP Vice President-Regulatory Affairs 8041 Arco Corporate Drive, Suite 20…
- Telix Pharmaceuticals (US) Inc. · NDA 218592
ADMINISTRATION ¢ YN U.S. FOOD & DRUG NDA 218592 COMPLETE RESPONSE Telix Pharmaceuticals (US) Inc. Attention: Lara Haddad RPh, RAC Manager, Global Regulatory Affairs 11700 Exit 5 Pkwy Suite 200 Fisher…
- PTC Therapeutics, Inc. · NDA 220049
ADMINISTRATION ¢ YN U.S. FOOD & DRUG NDA 220049 COMPLETE RESPONSE PTC Therapeutics, Inc. Attention: Aparna Geddam, MS Director, Global Regulatory Strategy 500 Warren Corporate Center Drive Warren, NJ…
- Stealth BioTherapeutics Inc. · NDA 215244
i Lk YN U.S. FOOD & DRUG ADMINISTRATION NDA 215244 COMPLETE RESPONSE Stealth BioTherapeutics Inc. Attention: Jim Carr Chief Clinical Development Officer 123 Highland Avenue, Suite 201 Needham, MA 024…
- Elevar Therapeutics, Inc. · NDA 216586
ind U.S. FOOD & DRUG ADMINISTRATION q NDA 216586 COMPLETE RESPONSE Elevar Therapeutics, Inc. Attention: Young-Sil (Anna) Yim Senior Director, Regulatory Affairs One Bridge Plaza, Suite 850 Fort Lee,…
- Hospira, Inc. · NDA 219112
a g PN U.S. FOOD & DRUG ADMINISTRATION NDA 219112 COMPLETE RESPONSE Hospira, Inc. Attention: Arman Nolledo Regulatory Affairs Manager 275 N Field Dr, D-389 BLDG H2 Lake Forest, IL 60045 Dear Arman No…
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.