FDA — authorised 25 August 2021
- Application: BLA761177
- Marketing authorisation holder: ASCENDIS PHARMA ENCOCRINOLOGY DIV A/S
- Indication: Type 1 - New Molecular Entity
- Status: approved
🇺🇸 SKYTROFA in United States
FDA authorised SKYTROFA on 25 August 2021
Marketing authorisation
SKYTROFA in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is SKYTROFA approved in United States?
Yes. FDA authorised it on 25 August 2021.
Who is the marketing authorisation holder for SKYTROFA in United States?
ASCENDIS PHARMA ENCOCRINOLOGY DIV A/S holds the US marketing authorisation.