Source facts
FDA issued an approval letter for WELIREG on 2026-06-16. The source metadata identifies NDA 215383 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
WELIREG — FDA Approval Letter (NDA 215383)
Issued to MERCK SHARP DOHME. Application is approved as submitted.
Issued
June 16, 2026Application
NDA 505b1 • 215383
Product
WELIREG
Company
MERCK SHARP DOHME
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for WELIREG?
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Key details in this letter
- 1FDA action: approval.
- 2Application: NDA 215383.
- 3Submission: supplement.
- 4Sponsor: MERCK SHARP DOHME.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the WELIREG approval letter
Is WELIREG FDA approved?
This letter documents an FDA approval action: FDA approved NDA 215383 for WELIREG, sponsored by MERCK SHARP DOHME, on June 16, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 215383?
NDA 215383 is the application under which FDA issued this approval letter for WELIREG to MERCK SHARP DOHME. The letter is dated June 16, 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.