Is Semaglutide Legal? Regulatory Status by Country
As of November 3, 2026: United States — FDA-approved (prescription); European Union — Authorised (EU centralised procedure); Canada — Authorized (Health Canada). Status differs by country; see the table for official sources and dates.
Last reviewed: Data retrieved:
Status by jurisdiction
| Jurisdiction | Status | Basis | Official source | Retrieved |
|---|---|---|---|---|
| United States | FDA-approved (prescription) | Listed in Drugs@FDA as Ozempic (NDA 209637, subcutaneous solution) and Wegovy (NDA 215256, subcutaneous solution), applicant Novo Nordisk. Oral tablet applications are also listed (NDA 213051, NDA 218316). Approved indications are defined in the current FDA labels. | Drugs@FDA: Ozempic (semaglutide), NDA 209637 | |
| European Union | Authorised (EU centralised procedure) | EMA lists Ozempic (semaglutide) as authorised, with the marketing authorisation issued on 8 February 2018 (therapeutic area: diabetes mellitus). EMA also lists Wegovy (semaglutide) as authorised; its EMA overview describes use for weight management in adults with obesity or overweight with weight-related health problems, and in adolescents from 12 years of age with obesity. | EMA EPAR: Ozempic (semaglutide) | |
| United Kingdom | No data | |||
| Canada | Authorized (Health Canada) | The Health Canada Drug Product Database lists OZEMPIC (semaglutide) with current status Marketed and original market date 2018-02-22. It also lists WEGOVY (semaglutide, single-dose prefilled pen) with current status Approved and current status date 2021-11-23. | Health Canada Drug Product Database: OZEMPIC (semaglutide) | |
| Australia | No data | |||
| Japan | No data | |||
| China | No data | |||
| WADA (sport) | No data | |||
How to read this table
- "Not approved" means no marketing authorization was identified in the cited source. It is not a statement about the legality of possession, import, or research use.
- "Approved for other indications" means a product containing the substance is authorized, but only for the conditions named on its label.
- Compounding categories refer to U.S. FDA lists for bulk drug substances used by compounding pharmacies, where applicable.
- "Prohibited in sport" reflects the WADA Prohibited List, which applies to athletes under anti-doping rules regardless of national drug law.
- Products labeled "for research use only" are not authorized for human use by that labeling.
- "No data" means no official source has been reviewed yet for that jurisdiction.
This page is descriptive. It is not legal advice.
Changelog
- — United States: US row added from Drugs@FDA.
- — European Union: EU row added from EMA EPAR pages.
- — Canada: CA row added from Health Canada Drug Product Database.
Frequently asked questions
Is Semaglutide FDA approved?
As of November 3, 2026, the United States entry reads "FDA-approved (prescription)". Listed in Drugs@FDA as Ozempic (NDA 209637, subcutaneous solution) and Wegovy (NDA 215256, subcutaneous solution), applicant Novo Nordisk. Oral tablet applications are also listed (NDA 213051, NDA 218316). Approved indications are defined in the current FDA labels. Source: Drugs@FDA: Ozempic (semaglutide), NDA 209637. See the table above for other jurisdictions.
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