← FDA DRUG APPROVALS

FDA NDA · NDA217677

OGSIVEO

nirogacestat

Sponsor: SPRINGWORKS

APPLICATION
NDA217677
TYPE
NDA
ORIGINAL APPROVAL
2023-11-27
LATEST ACTION
2026-07-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription, Discontinued

Products

OGSIVEO · ReferencePrescription
NIROGACESTAT HYDROBROMIDE EQ 100MG BASE · TABLET · ORAL
OGSIVEO · ReferencePrescription
NIROGACESTAT HYDROBROMIDE EQ 150MG BASE · TABLET · ORAL
OGSIVEO · ReferenceDiscontinued
NIROGACESTAT HYDROBROMIDE EQ 50MG BASE · TABLET · ORAL

Approval history

2026-07-17Labeling · Supplement 8 · standard — Label ↗AP
2026-03-10Labeling · Supplement 6 · standard — Letter ↗AP
2024-04-04Manufacturing (CMC) · Supplement 1 — Label ↗AP
2023-11-27Type 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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