Source facts
FDA issued an approval letter for WEGOVY, WEGOVY HD, WEGOVY FLEXTOUCH on 2026-02-27. The source metadata identifies NDA 215256, NDA 218316 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
WEGOVY / WEGOVY HD / WEGOVY FLEXTOUCH — FDA Approval Letter (NDA 215256)
Issued to NOVO. Application is approved as submitted.
Issued
February 27, 2026Application
NDA 505b1 • 215256
Product
WEGOVY / WEGOVY HD / WEGOVY FLEXTOUCH
Company
NOVO
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for WEGOVY / WEGOVY HD / WEGOVY FLEXTOUCH?
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Key details in this letter
- 1FDA action: approval.
- 2Applications: NDA 215256, NDA 218316.
- 3Submission: supplement.
- 4Sponsor: NOVO.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the WEGOVY / WEGOVY HD / WEGOVY FLEXTOUCH approval letter
Is WEGOVY / WEGOVY HD / WEGOVY FLEXTOUCH FDA approved?
This letter documents an FDA approval action: FDA approved NDA 215256 for WEGOVY / WEGOVY HD / WEGOVY FLEXTOUCH, sponsored by NOVO, on February 27, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 215256?
NDA 215256 is the application under which FDA issued this approval letter for WEGOVY / WEGOVY HD / WEGOVY FLEXTOUCH to NOVO. The letter is dated February 27, 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.