FDA — authorised 23 December 2014
- Application: NDA206321
- Marketing authorisation holder: NOVO
- Local brand name: SAXENDA
- Indication: SOLUTION — SUBCUTANEOUS
- Status: approved
🇺🇸 Saxenda in United States
FDA authorised Saxenda on 23 December 2014
Marketing authorisations
FDA — authorised 24 February 2026
- Application: ANDA217063
- Marketing authorisation holder: BIOCON PHARMA
- Local brand name: LIRAGLUTIDE
- Indication: SOLUTION — SUBCUTANEOUS
- Status: approved
FDA — authorised 11 March 2026
- Application: ANDA215245
- Marketing authorisation holder: BIOCON PHARMA
- Local brand name: LIRAGLUTIDE
- Indication: SOLUTION — SUBCUTANEOUS
- Status: approved
The FDA approved Saxenda (Liraglutide) injection for subcutaneous use on 11 March 2026. This approval was granted to Biocon Pharma under the standard expedited pathway. Saxenda is indicated for the treatment of obesity in adults with a body mass index (BMI) of 30 kg/m² or higher, or in adults with a BMI of 27 kg/m² or higher with at least one weight-related condition.
FDA — authorised 30 March 2026
- Application: ANDA212552
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: LIRAGLUTIDE
- Indication: SOLUTION — SUBCUTANEOUS
- Status: approved
FDA
- Status: approved
Saxenda in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Saxenda approved in United States?
Yes. FDA authorised it on 23 December 2014; FDA authorised it on 24 February 2026; FDA authorised it on 11 March 2026.
Who is the marketing authorisation holder for Saxenda in United States?
NOVO holds the US marketing authorisation.