🇺🇸 Mitapivat tablet in United States

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

FDA authorised Mitapivat tablet on 17 February 2022

Marketing authorisation

FDA — authorised 17 February 2022

Application: NDA216196
Marketing authorisation holder: AGIOS PHARMS INC
Local brand name: AQVESME
Indication: TABLET — ORAL
Status: approved

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Frequently asked questions

Is Mitapivat tablet approved in United States?

Yes. FDA authorised it on 17 February 2022.

Who is the marketing authorisation holder for Mitapivat tablet in United States?

AGIOS PHARMS INC holds the US marketing authorisation.