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FDA NDA · NDA212608

AYVAKIT

Sponsor: BLUEPRINT MEDICINES

APPLICATION
NDA212608
TYPE
NDA
ORIGINAL APPROVAL
2020-01-09
LATEST ACTION
2024-11-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

AYVAKIT · ReferencePrescription
AVAPRITINIB 50MG · TABLET · ORAL
AYVAKIT · ReferencePrescription
AVAPRITINIB 300MG · TABLET · ORAL
AYVAKIT · ReferencePrescription
AVAPRITINIB 100MG · TABLET · ORAL
AYVAKIT · ReferencePrescription
AVAPRITINIB 25MG · TABLET · ORAL
AYVAKIT · ReferencePrescription
AVAPRITINIB 200MG · TABLET · ORAL

Approval history

2024-11-08Labeling · Supplement 20 · standard — Label ↗AP
2023-05-22Efficacy · Supplement 13 · priority — Label ↗AP
2023-03-09Labeling · Supplement 12 · standard — Letter ↗AP
2021-06-16Efficacy · Supplement 6 · priority — Label ↗AP
2021-06-16Efficacy · Supplement 7 · priority — Label ↗AP
2020-01-09Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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