← FDA DRUG APPROVALS

FDA NDA · NDA208772

ALUNBRIG

brigatinib

Sponsor: TAKEDA PHARMS USA

APPLICATION
NDA208772
TYPE
NDA
ORIGINAL APPROVAL
2017-04-28
LATEST ACTION
2022-02-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

ALUNBRIG · ReferencePrescription
BRIGATINIB 180MG · TABLET · ORAL
ALUNBRIG · ReferencePrescription
BRIGATINIB 30MG · TABLET · ORAL
ALUNBRIG · ReferencePrescription
BRIGATINIB 90MG · TABLET · ORAL

Approval history

2022-02-28Efficacy · Supplement 13 · standard — Letter ↗AP
2021-09-24Labeling · Supplement 12 · standard — Letter ↗AP
2020-05-22Efficacy · Supplement 8 · priority — Label ↗AP
2018-12-21Efficacy · Supplement 4 · standard — Label ↗AP
2017-10-02Manufacturing (CMC) · Supplement 2AP
2017-04-28Type 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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →