← FDA DRUG APPROVALS

FDA BLA · BLA125327

VORAXAZE

glucarpidase

Sponsor: BTG INTERNATIONAL INC

APPLICATION
BLA125327
TYPE
BLA
ORIGINAL APPROVAL
2012-01-17
LATEST ACTION
2019-08-13
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

VORAXAZEPrescription
GLUCARPIDASE 1000 UNITS PER VIAL · INJECTABLE · INJECTION

Approval history

2019-08-13Labeling · Supplement 64 · standard — Letter ↗AP
2013-03-29Labeling · Supplement 20 · standard — Label ↗AP
2012-01-17Type 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 →