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FDA BLA · BLA761047

MEPSEVII

vestronidase alfa

Sponsor: ULTRAGENYX PHARM INC

APPLICATION
BLA761047
TYPE
BLA
ORIGINAL APPROVAL
2017-11-15
LATEST ACTION
2020-12-23
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

MEPSEVIIPrescription
VESTRONIDASE ALFA-VJBK 10MG/5ML · INJECTABLE · INJECTION

Approval history

2020-12-23Efficacy · Supplement 5 · standard — Label ↗AP
2019-12-06Labeling · Supplement 3 · standard — Label ↗AP
2017-11-15Type 1 - New Molecular Entity · Original · priority — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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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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