FDA — authorised 24 February 2014
- Marketing authorisation holder: AMYLIN PHARMS LLC
- Status: approved
🇺🇸 Myalept in United States
FDA authorised Myalept on 24 February 2014
Marketing authorisations
FDA — authorised 24 February 2014
- Application: BLA125390
- Marketing authorisation holder: CHIESI FARMACEUTICI SPA
- Local brand name: MYALEPT
- Indication: INJECTABLE — INJECTION
- Status: approved
Myalept 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 Myalept approved in United States?
Yes. FDA authorised it on 24 February 2014; FDA authorised it on 24 February 2014.
Who is the marketing authorisation holder for Myalept in United States?
AMYLIN PHARMS LLC holds the US marketing authorisation.