FDA — authorised 28 February 2023
- Marketing authorisation holder: REATA PHARMACEUTICALS INC
- Status: approved
🇺🇸 Skyclarys in United States
FDA authorised Skyclarys on 28 February 2023
Marketing authorisations
FDA — authorised 28 February 2023
- Application: NDA216718
- Marketing authorisation holder: BIOGEN US
- Local brand name: SKYCLARYS
- Indication: CAPSULE — ORAL
- Status: approved
Skyclarys 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 Skyclarys approved in United States?
Yes. FDA authorised it on 28 February 2023; FDA authorised it on 28 February 2023.
Who is the marketing authorisation holder for Skyclarys in United States?
REATA PHARMACEUTICALS INC holds the US marketing authorisation.