FDA — authorised 25 August 2021
- Marketing authorisation holder: ASCENDIS PHARMA ENCOCRINOLOGY DIV A/S
- Status: approved
🇺🇸 Skytrofa in United States
FDA authorised Skytrofa on 25 August 2021
Marketing authorisations
FDA — authorised 25 August 2021
- Application: BLA761177
- Marketing authorisation holder: ASCENDIS PHARMA ENCOCRINOLOGY DIV A/S
- Local brand name: SKYTROFA
- Indication: INJECTABLE — INJECTION
- Status: approved
Skytrofa in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Skytrofa approved in United States?
Yes. FDA authorised it on 25 August 2021; 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.