Source facts
FDA issued an approval letter for INREBIC on 2026-03-20. The source metadata identifies NDA 212327 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
INREBIC — FDA Approval Letter (NDA 212327)
Issued to BRISTOL-MYERS. Application is approved as submitted.
Issued
March 20, 2026Application
NDA 505b1 • 212327
Product
INREBIC
Company
BRISTOL-MYERS
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for INREBIC?
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Key details in this letter
- 1FDA action: approval.
- 2Application: NDA 212327.
- 3Submission: supplement.
- 4Sponsor: BRISTOL-MYERS.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the INREBIC approval letter
Is INREBIC FDA approved?
This letter documents an FDA approval action: FDA approved NDA 212327 for INREBIC, sponsored by BRISTOL-MYERS, on March 20, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 212327?
NDA 212327 is the application under which FDA issued this approval letter for INREBIC to BRISTOL-MYERS. The letter is dated March 20, 2026.
What happens after an FDA approval letter?
The sponsor may market the product in line with the approved labeling. Approval letters typically set post-approval obligations: submitting final content of labeling, meeting any postmarketing requirements or commitments listed in the letter, updating Orange Book patent information within 30 days for NDAs, and ongoing annual reporting under 21 CFR 314.81.