FDA — authorised 25 February 2021
- Application: NDA213026
- Marketing authorisation holder: SAREPTA THERAPS INC
- Local brand name: AMONDYS 45
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
🇺🇸 Amondys 45 in United States
FDA authorised Amondys 45 on 25 February 2021
Marketing authorisation
Amondys 45 in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Rare Disease approved in United States
Frequently asked questions
Is Amondys 45 approved in United States?
Yes. FDA authorised it on 25 February 2021.
Who is the marketing authorisation holder for Amondys 45 in United States?
SAREPTA THERAPS INC holds the US marketing authorisation.