Semaglutide
WEGOVY
WEGOVY is an FDA-approved semaglutide prescription product with a product-specific label. That approval does not transfer to every item advertised with the ingredient name semaglutide.
The ingredient name is broader than this one approved product record.
The FDA application number anchors the exact US product history.
DailyMed's current WEGOVY label contains both presentations.
The current label carries a boxed warning about thyroid C-cell tumors.
Resolve the application before the claim.
- Brand
- WEGOVY
- Active ingredient
- Semaglutide
- US application
- NDA 215256
- Company named in current label
- Novo Nordisk Inc.
- Dosage form
- Injection and tablets
- Route
- Subcutaneous and oral
- Approval record
- WEGOVY NDA first approved in 2021
- Label record updated
- June 18, 2026
What this approval covers - and what it does not.
This summary stays intentionally high level. Use the current full prescribing information for complete warnings, contraindications, adverse reactions, and instructions.
The exact approved record
The current US label covers chronic weight management in specified adults and adolescents, cardiovascular-risk reduction in specified adults, and treatment of noncirrhotic MASH with moderate-to-advanced fibrosis in specified adults. Eligibility and presentation differ across the labeled uses.
Open current label ↗An ingredient match is not product equivalence
This record describes WEGOVY under NDA 215256. Ozempic and Rybelsus are separate semaglutide products with separate labels, and compounded or unapproved semaglutide products do not inherit WEGOVY's approval, manufacturing review, indications, or presentation.
Read the category guide →Semaglutide across 42 countries.
This record starts with the exact US FDA medicine identity. The global and state maps keep authorization, presentation, prescription route, market status, pharmacy, and seller records separate.
Compare Semaglutide by country →Compare Semaglutide by US state →The questions behind the medicine search.
Answers are based on the dated FDA and DailyMed records below. They are educational reporting, not a diagnosis, prescription, or treatment recommendation.
Are semaglutide and Wegovy the same thing?
Semaglutide is the active ingredient in WEGOVY, but the terms are not interchangeable across every product. WEGOVY is the product reviewed under NDA 215256. Other approved semaglutide brands have different applications and labels, while compounded and unapproved products sit outside this approval record.
What is Wegovy FDA approved for?
The current label includes several uses in defined populations: chronic weight management, cardiovascular-risk reduction, and noncirrhotic MASH with specified fibrosis. The full prescribing information defines the exact population and presentation for each use; this page does not determine whether a person meets those criteria.
Where can I verify the current Wegovy label?
Use the current DailyMed record for the labeling in use and FDA's Drugs@FDA application page for NDA 215256. Both primary links are listed below, with the date each record was checked.
Is semaglutide approved and available in every country?
No single ingredient-level answer applies worldwide. WEGOVY has product-specific authorizations in the United States and European Union, while Canada authorized new generic semaglutide products in 2026 and France applies its own prescribing and reimbursement rules. Other destinations have separate product records, brands, indications, presentations, prescription requirements, market status, and seller controls. The worldwide map linked below routes each country search to its official product and seller records.
Use the current full prescribing information and a licensed clinician or pharmacist for medicine-specific decisions. Do not substitute a research product, investigational program, or unapproved seller listing for an FDA-approved product.
Open safety and verification resources →