Complete response letters
FDA's letters telling drug and biologic applicants why an application was not approved as submitted. 458 records; openFDA updated it 2026-11-10. About this dataset
Newest records
- Approved309
- Unapproved149
- Ferring Pharmaceuticals Inc. · BLA 761253
PrN U.S. FOOD & DRUG ADMINISTRATION BLA 761253 COMPLETE RESPONSE Ferring Pharmaceuticals Inc. Attention: Sangeeta Chavan Patil Director, Regulatory Affairs 100 Interpace Parkway Parsippany, NJ 07054…
- Amphastar Pharmaceuticals, Inc. · BLA 761403
PN U.S. FOOD & DRUG ADMINISTRATION BLA 761403 COMPLETE RESPONSE Amphastar Pharmaceuticals, Inc. Attention: Magda Albedrop, RAC-Drugs Senior Supervisor of the CMC and Submissions Group Regulatory Affa…
- Achieve Life Sciences, Inc. · NDA 218995
ADMINISTRATION i Lk YN U.S. FOOD & DRUG NDA 218995 COMPLETE RESPONSE Achieve Life Sciences, Inc. 22722 29th Dr. SE, Suite 100 Bothell, WA 98021 Attention: | Sarah Telzrow Vice President, Regulatory A…
- Evergreen Theragnostics, Inc. · NDA 216900
PN U.S. FOOD & DRUG ADMINISTRATION NDA 216900 COMPLETE RESPONSE Evergreen Theragnostics, Inc. C/o Bourque Regulatory CMC, Inc. Attention: Mr. Jeffrey Bourque President, Bourque Regulatory CMC, Inc. 2…
- Tris Pharma, Inc. · NDA 220138
i Lk YN U.S. FOOD & DRUG ADMINISTRATION NDA 220138 COMPLETE RESPONSE Tris Pharma, Inc. Attention: Rashmi Aravind Senior Director of Regulatory Affairs 2033 Route 130 Suite #D Monmouth Junction, NJ 08…
- Grace Therapeutics U.S., Inc. · NDA 220304
g U.S. FOOD & DRUG Naty ADMINISTRATION NDA 220304 COMPLETE RESPONSE Grace Therapeutics U.S., Inc. Attention: Amresh Kumar Vice President of Program Management 103 Carnegie Center Drive, Suite 300 Pri…
- AbbVie Inc. · BLA 761459
nN U.S. FOOD & DRUG ADMINISTRATION BLA 761459 COMPLETE RESPONSE AbbVie Inc. Attention: Felipe Martins Associate Director, Regulatory Affairs 2525 Dupont Drive Irvine, CA 92612 Dear Felipe Martins: Pl…
- 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…
- Tanvex BioPharma USA, Inc. · BLA 761266
i Lk YN U.S. FOOD & DRUG ADMINISTRATION BLA 761266 COMPLETE RESPONSE Tanvex BioPharma USA, Inc. Attention: Bonnie J. Mills, PhD 10394 Pacific Center Court San Diego, CA 92121 Dear Dr. Mills: Please r…
- 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…
- NeuroDerm, Ltd. · NDA 218317
ADMINISTRATION f ¢ yy U.S. FOOD & DRUG NDA 218317 COMPLETE RESPONSE NeuroDerm, Ltd. c/o: The ProPharma Group Attention: Daniel Solorio Senior Vice President, Regulatory Program Management 1129 20th S…
- Seikagaku Corporation · BLA 761393
IN U.S. FOOD & DRUG ADMINISTRATION Net BLA 761393 COMPLETE RESPONSE Seikagaku Corporation c/o PAREXEL International 2520 Meridian Parkway, Suite 100 Durham, NC 27713 Attention: Katherine Fertal US Ag…
- Immedica Pharma AB · BLA 761211
IN U.S. FOOD & DRUG Se ADMINISTRATION BLA 761211 COMPLETE RESPONSE Immedica Pharma AB % DLRC Inc. Attention: Gregory Dombal President 1 Broadway Cambridge, MA 02142 Dear Gregory Dombal: Please refer…
- Tanvex BioPharma USA, Inc. · BLA 761266
ADMINISTRATION i Lk YN U.S. FOOD & DRUG BLA 761266 COMPLETE RESPONSE Tanvex BioPharma USA, Inc. Attention: Bonnie Mills, PhD Regulatory Consultant 2030 Main Street, Suite 600 Irvine, CA 92614 Dear Dr…
- Milestone Pharmaceuticals USA, Inc. · NDA 218571
IN U.S. FOOD & DRUG ADMINISTRATION Net NDA 218571 COMPLETE RESPONSE Milestone Pharmaceuticals USA, Inc. Attention: Joseph Oliveto CEO 6210 Ardrey Kell Rd., Suite 650 Charlotte, NC 28277 Dear Joseph O…
- Alvotech USA Inc. · BLA 761435
Lk U.S. FOOD & DRUG “a ADMINISTRATION BLA 761435 COMPLETE RESPONSE Alvotech USA Inc. c/o Cencora Global Consulting Service Attention: Anusha Kesireddy Manager, Regulatory Affairs 1 West 1st Avenue Co…
- Conjupro Biotherapeutics Inc. · NDA 218923
YN U.S. FOOD & DRUG ADMINISTRATION NDA 218923 COMPLETE RESPONSE Conjupro Biotherapeutics Inc. Attention: Xi-De Wang, Ph.D., RAC Vice President, Regulatory Science & Compliance 302 Carnegie Center, Su…
- SFJ Pharmaceuticals, Inc. · BLA 761290
a g PN U.S. FOOD & DRUG ADMINISTRATION BLA 761290 COMPLETE RESPONSE SFJ Pharmaceuticals, Inc. Attention: Michele LaRussa SVP, Chief Regulatory Officer 109 Grey Bridge Row Cary, NC 27513 Dear Michele…
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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.