Source facts
FDA issued an approval letter for THALOMID on 2026-05-01. The source metadata identifies NDA 020785 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
THALOMID — FDA Approval Letter (NDA 020785)
Issued to BRISTOL-MYERS. Application is approved as submitted.
Issued
May 1, 2026Application
NDA 505b1 • 020785
Product
THALOMID
Company
BRISTOL-MYERS
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for THALOMID?
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
- 1FDA action: approval.
- 2Application: NDA 020785.
- 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 THALOMID approval letter
Is THALOMID FDA approved?
This letter documents an FDA approval action: FDA approved NDA 020785 for THALOMID, sponsored by BRISTOL-MYERS, on May 1, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 020785?
NDA 020785 is the application under which FDA issued this approval letter for THALOMID to BRISTOL-MYERS. The letter is dated May 1, 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.