← FDA DRUG APPROVALS

FDA NDA · NDA219908

REVTORPYK

gedatolisib

Sponsor: CELCUITY

APPLICATION
NDA219908
TYPE
NDA
ORIGINAL APPROVAL
2026-07-14
LATEST ACTION
2026-07-14
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

REVTORPYK · ReferencePrescription
GEDATOLISIB 180MG/VIAL · POWDER · INTRAVENOUS

Approval history

2026-07-14Type 1 - New Molecular Entity · Original · priorityLetterAP
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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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