FDA — authorised 19 September 2016
- Application: NDA206488
- Marketing authorisation holder: SAREPTA THERAPS INC
- Local brand name: EXONDYS 51
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
🇺🇸 Exondys 51 in United States
FDA authorised Exondys 51 on 19 September 2016
Marketing authorisations
FDA
- 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.
Frequently asked questions
Is Exondys 51 approved in United States?
Yes. FDA authorised it on 19 September 2016; FDA has authorised it.
Who is the marketing authorisation holder for Exondys 51 in United States?
SAREPTA THERAPS INC holds the US marketing authorisation.