← FDA DRUG APPROVALS

FDA BLA · BLA761261

XENPOZYME

olipudase alfa-rpcp

Sponsor: GENZYME CORP

APPLICATION
BLA761261
TYPE
BLA
ORIGINAL APPROVAL
2022-08-31
LATEST ACTION
2024-12-20
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

XENPOZYMEPrescription
OLIPUDASE ALFA-RPCP 20MG · INJECTABLE · INJECTION

Approval history

2024-12-20Labeling · Supplement 4 · standard — Letter ↗AP
2023-12-05Labeling · Supplement 2 · standard — Letter ↗AP
2022-08-31Type 1 - New Molecular Entity · Original · priority — Letter ↗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.

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