FDA
- Status: approved
🇺🇸 Translarna in United States
Translarna (ATALUREN) regulatory status in United States.
Marketing authorisation
Translarna 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 Translarna approved in United States?
Yes. FDA has authorised it.
Who is the marketing authorisation holder for Translarna in United States?
PTC Therapeutics International Limited is the originator. The local marketing authorisation holder may differ — check the official source linked above.