Wegovy (semaglutide)

New dosage form

Region: 🇺🇸 US
Active substance: semaglutide
Company: Novo
Status: Approved
FDA approval: Mon 22 Dec 2025
Designations: New dosage form
Application: NDA218316
Official record: www.accessdata.fda.gov

Regulatory milestones

Mon 22 Dec 2025🇺🇸 FDA approval

FDA approves Wegovy (semaglutide): new dosage form

Novo; NDA218316; New dosage form; tablet · source

Same substance in other markets

🇪🇺 Wegovy Authorised · Novo Nordisk A/S
🇪🇺 Ozempic Authorised · Novo Nordisk A/S
🇪🇺 Kayshild Authorised · Novo Nordisk A/S
🇪🇺 Rybelsus Authorised · Novo Nordisk A/S
🇪🇺 Kyinsu Authorised · Novo Nordisk A/S

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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.