← FDA DRUG APPROVALS

FDA BLA · BLA761052

BRINEURA

cerliponase alfa

Sponsor: BIOMARIN PHARM

APPLICATION
BLA761052
TYPE
BLA
ORIGINAL APPROVAL
2017-04-27
LATEST ACTION
2024-07-24
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

BRINEURAPrescription
CERLIPONASE ALFA 30MG/ML · INJECTABLE · INJECTION

Approval history

2024-07-24Efficacy · Supplement 14 · standard — Letter ↗AP
2024-07-10Labeling · Supplement 16 · standard — Letter ↗AP
2020-03-27Labeling · Supplement 8 · standard — Letter ↗AP
2019-12-06Labeling · Supplement 7 · standard — Label ↗AP
2018-12-11Labeling · Supplement 3 · standard — Label ↗AP
2017-04-27Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Biologics 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 →