FDA — authorised 19 September 2016
- Marketing authorisation holder: SAREPTA THERAPEUTICS INC
- Status: approved
🇺🇸 Exondys 51 in United States
FDA authorised Exondys 51 on 19 September 2016
Marketing authorisations
FDA — authorised 7 July 2020
- Application: NDA206488
- Marketing authorisation holder: SAREPTA THERAPS INC
- Indication: Labeling
- Status: approved
Exondys 51 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 Exondys 51 approved in United States?
Yes. FDA authorised it on 19 September 2016; FDA authorised it on 7 July 2020.
Who is the marketing authorisation holder for Exondys 51 in United States?
SAREPTA THERAPEUTICS INC holds the US marketing authorisation.