FDA — authorised 15 April 2021
- Marketing authorisation holder: MAYNE PHARMA
- Status: approved
🇺🇸 Nextstellis in United States
FDA authorised Nextstellis on 15 April 2021
Marketing authorisations
FDA — authorised 15 April 2021
- Application: NDA214154
- Marketing authorisation holder: MAYNE PHARMA
- Local brand name: NEXTSTELLIS
- Indication: TABLET — ORAL
- Status: approved
Nextstellis 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 Nextstellis approved in United States?
Yes. FDA authorised it on 15 April 2021; FDA authorised it on 15 April 2021.
Who is the marketing authorisation holder for Nextstellis in United States?
MAYNE PHARMA holds the US marketing authorisation.