← FDA DRUG APPROVALS

FDA NDA · NDA213736

PEMAZYRE

pemigatinib

Sponsor: INCYTE CORP

APPLICATION
NDA213736
TYPE
NDA
ORIGINAL APPROVAL
2020-04-17
LATEST ACTION
2022-08-26
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

PEMAZYRE · ReferencePrescription
PEMIGATINIB 13.5MG · TABLET · ORAL
PEMAZYRE · ReferencePrescription
PEMIGATINIB 4.5MG · TABLET · ORAL
PEMAZYRE · ReferencePrescription
PEMIGATINIB 9MG · TABLET · ORAL

Approval history

2022-08-26Efficacy · Supplement 2 · priority — Label ↗AP
2021-02-23Labeling · Supplement 1 · standard — Label ↗AP
2020-04-17Type 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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