← FDA DRUG APPROVALS

FDA NDA · NDA216196

AQVESME

mitapivat

Sponsor: AGIOS PHARMS INC

APPLICATION
NDA216196
TYPE
NDA
ORIGINAL APPROVAL
2022-02-17
LATEST ACTION
2025-12-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

PYRUKYND · ReferencePrescription
MITAPIVAT SULFATE EQ 20MG BASE · TABLET · ORAL
PYRUKYND · ReferencePrescription
MITAPIVAT SULFATE EQ 50MG BASE · TABLET · ORAL
PYRUKYND · ReferencePrescription
MITAPIVAT SULFATE EQ 5MG BASE · TABLET · ORAL
AQVESME · ReferencePrescription
MITAPIVAT SULFATE EQ 100MG BASE · TABLET · ORAL

Approval history

2025-12-23Efficacy · Supplement 3 · standard — Label ↗AP
2025-01-03Labeling · Supplement 4 · standard — Letter ↗AP
2022-02-17Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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