← FDA DRUG APPROVALS

FDA NDA · NDA213721

GAVRETO

pralsetinib

Sponsor: RIGEL PHARMS

APPLICATION
NDA213721
TYPE
NDA
ORIGINAL APPROVAL
2020-09-04
LATEST ACTION
2025-12-22
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

GAVRETO · ReferencePrescription
PRALSETINIB 100MG · CAPSULE · ORAL

Approval history

2025-12-22Labeling · Supplement 16 · standard — Letter ↗AP
2024-03-22Labeling · Supplement 15 · standard — Label ↗AP
2023-08-09Efficacy · Supplement 9 · standard — Letter ↗AP
2023-07-20Labeling · Supplement 14 · standard — Letter ↗AP
2023-06-30Labeling · Supplement 11 · standard — Letter ↗AP
2022-09-28Labeling · Supplement 7 · standard — Label ↗AP
2022-02-02Labeling · Supplement 5 · standard — Letter ↗AP
2021-11-10Labeling · Supplement 4 · standard — Letter ↗AP
2020-09-04Type 1 - New Molecular Entity · Supplement 1 · priority — Label ↗AP
2020-09-04Type 1 - New Molecular Entity · Original · priority — Review ↗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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