Source facts
FDA's complete response letter contains source-text evidence related to Facility inspection and CGMP compliance. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
US FDA source recordCRL · Complete Response Letter
BLA 761376 — FDA Complete Response Letter
Issued to Dr. Reddy’s Laboratories SA. Application reviewed but not approved; deficiencies must be corrected.
Issued
October 16, 2025Application
BLA • 761376
Product
BLA 761376
Company
Dr. Reddy’s Laboratories SA
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for BLA 761376?
Source facts and Assyro context are separated so you can scan the action quickly without treating analysis as an FDA conclusion.
Key details in this letter
- 1Facility inspection and CGMP compliance: 3 source-text matches.
Facility inspection and CGMP compliance
Suggested next step
Review the exact redacted FDA letter and address each stated deficiency before resubmission.
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Common questions about the BLA 761376 complete response letter
What does this complete response letter mean for BLA 761376?
Application reviewed but not approved; deficiencies must be corrected. Requires resubmission addressing deficiencies. FDA issued this letter to Dr. Reddy’s Laboratories SA on October 16, 2025.
What is BLA 761376?
BLA 761376 is the application under which FDA issued this complete response letter to Dr. Reddy’s Laboratories SA. The letter is dated October 16, 2025.
What happens after an FDA complete response letter?
FDA will not approve the application in its present form. The sponsor can resubmit after addressing every deficiency listed in the letter — which starts a Class 1 (two-month) or Class 2 (six-month) resubmission review clock — withdraw the application, or request an opportunity for a hearing.