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
- CELLTRION, Inc. · BLA 761377
i Lk YN U.S. FOOD & DRUG ADMINISTRATION BLA 761377 COMPLETE RESPONSE CELLTRION, Inc. c/o Parexel International Attention: Ally Danta Regulatory Affairs Consultant 2520 Meridian Parkway, Suite 100 Dur…
- AstraZeneca Pharmaceuticals LP · BLA 761451
Cg YN U.S. FOOD & DRUG ADMINISTRATION BLA 761451 COMPLETE RESPONSE AstraZeneca Pharmaceuticals LP Attention: Osamah Al-Qaysi Associate Regulatory Affairs Director One Medimmune Way Gaithersburg, MD 2…
- Aldeyra Therapeutics, Inc. · NDA 216442
Lg my U.S. FOOD & DRUG Ny, ADMINISTRATION NDA 216442 COMPLETE RESPONSE Aldeyra Therapeutics, Inc. Attention: David Noskowitz Regulatory Affairs Consultant 131 Hartwell Ave., Suite 320 Lexington, MA 0…
- Replimune, Inc. · BL 125827
i Lg YN U.S. FOOD & DRUG ADMINISTRATION Our STN: BL 125827 COMPLETE RESPONSE JULY 21, 2025 Replimune, Inc. Attention: Kari Jeschke 500 Unicorn Park Drive Woburn, MA 01801 Dear Kari Jeschke: Please re…
- Accord BioPharma Inc. · BLA 761424
IN U.S. FOOD & DRUG ADMINISTRATION BLA 761424 COMPLETE RESPONSE Accord BioPharma Inc. Attention: Sabita Nair VP Regulatory Affairs 8041 Arco Corporate Drive, Suite 200 Raleigh, NC 27617 Dear Sabita N…
- Sun Pharmaceutical Industries Limited · NDA 215644
f ¢ yy U.S. FOOD & DRUG ADMINISTRATION Net NDA 215644 COMPLETE RESPONSE Sun Pharmaceutical Industries Limited C/O: Sun Pharmaceutical Industries, Inc. Attention: Umesh Pai, US Agent 2 Independence Wa…
- Saol International Development Limited · NDA 218679
ADMINISTRATION i Lk YN U.S. FOOD & DRUG NDA 218679 COMPLETE RESPONSE Saol International Development Limited % Saol Therapeutics Inc Attention: Allison Lowry Head of Regulatory 1000 Holcomb Woods Park…
- Dr. Reddy’s Laboratories SA · BLA 761376
ADMINISTRATION i Lk YN U.S. FOOD & DRUG BLA 761376 COMPLETE RESPONSE Dr. Reddy’s Laboratories SA c/o Parexel International Attention: Ally Danta Regulatory Affairs Consultant 541 Church at North Hill…
- Teva Pharmaceuticals, Inc. · BLA 761385
i Lk YN U.S. FOOD & DRUG ADMINISTRATION BLA 761385 COMPLETE RESPONSE Teva Pharmaceuticals, Inc. Attention: David DeCicco Director, Global Biosimilar Regulatory Affairs 145 Brandywine Parkway West Che…
- 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…
- Outlook Therapeutics, Inc. · BLA 761320
Lg my U.S. FOOD & DRUG Ny, ADMINISTRATION BLA 761320 COMPLETE RESPONSE Outlook Therapeutics, Inc. Attention: Jennifer Kissner, PhD Executive Vice President 111 South Wood Avenue Unit #100 Iselin, NJ…
- Shanghai Auzone Biological Technology Co., Ltd. · NDA 219846
IN U.S. FOOD & DRUG ADMINISTRATION NDA 219846 COMPLETE RESPONSE Shanghai Auzone Biological Technology Co., Ltd. c/o WuXi AppTec Attention: Janet R Rea Regulatory Consultant 23 Woodland Dr. Newport, W…
- 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…
- GlaxoSmithKline LLC · BLA 761458/Original 2,BLA 761458
f ¢ PN U.S. FOOD & DRUG “en ADMINISTRATION BLA 761458/Original 2 COMPLETE RESPONSE GlaxoSmithKline LLC Attention: David Colton Director, Global Regulatory Affairs 200 Cambridge Park Drive Cambridge,…
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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.