← FDA DRUG APPROVALS

FDA BLA · BLA761278

LAMZEDE

velmanase alfa-tycv

Sponsor: CHIESI FARMACEUTICI SPA

APPLICATION
BLA761278
TYPE
BLA
ORIGINAL APPROVAL
2023-02-16
LATEST ACTION
2023-02-16
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER, FOR INJECTION SOLUTION, LYOPHILIZED POWDER
MARKETING STATUS
Prescription

Products

LAMZEDEPrescription
VELMANASE ALFA-TYCV 10MG · POWDER, FOR INJECTION SOLUTION, LYOPHILIZED POWDER

Approval history

2023-02-16Type 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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