← FDA DRUG APPROVALS

FDA BLA · BLA761092

REVCOVI

elapegademase-lvlr

Sponsor: CHIESI USA INC

APPLICATION
BLA761092
TYPE
BLA
ORIGINAL APPROVAL
2018-10-05
LATEST ACTION
2020-12-05
ROUTE
INTRAMUSCULAR, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

REVCOVIPrescription
ELAPEGADEMASE-LVLR 1.6MG/ML · INJECTABLE · INJECTION

Approval history

2020-12-05Labeling · Supplement 5 · standard — Label ↗AP
2018-10-05Type 1 - New Molecular Entity · Original · standard — 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.

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