FDA — authorised 25 November 2019
- Marketing authorisation holder: GLOBAL BLOOD THERAPEUTICS INC
- Status: approved
🇺🇸 Oxbryta in United States
FDA authorised Oxbryta on 25 November 2019
Marketing authorisations
FDA — authorised 25 November 2019
- Application: NDA213137
- Marketing authorisation holder: GLOBAL BLOOD THERAPS
- Local brand name: OXBRYTA
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 December 2021
- Application: NDA216157
- Marketing authorisation holder: GLOBAL BLOOD THERAPS
- Local brand name: OXBRYTA
- Indication: TABLET — ORAL
- Status: approved
Oxbryta in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Hematology approved in United States
Frequently asked questions
Is Oxbryta approved in United States?
Yes. FDA authorised it on 25 November 2019; FDA authorised it on 25 November 2019; FDA authorised it on 17 December 2021.
Who is the marketing authorisation holder for Oxbryta in United States?
GLOBAL BLOOD THERAPEUTICS INC holds the US marketing authorisation.