FDA — authorised 15 November 2019
- Marketing authorisation holder: NOVARTIS PHARMS CORP
- Status: approved
🇺🇸 Selg1 in United States
FDA authorised Selg1 on 15 November 2019
Marketing authorisations
FDA — authorised 26 June 2024
- Application: BLA761128
- Marketing authorisation holder: NOVARTIS PHARMS CORP
- Indication: Efficacy
- Status: approved
The FDA approved Selg1, a drug developed by Novartis Pharms Corp, for its approved indication on June 26, 2024. The application number for this approval is BLA761128. This approval was granted through the standard expedited pathway.
Selg1 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 Selg1 approved in United States?
Yes. FDA authorised it on 15 November 2019; FDA authorised it on 26 June 2024.
Who is the marketing authorisation holder for Selg1 in United States?
NOVARTIS PHARMS CORP holds the US marketing authorisation.