← FDA DRUG APPROVALS

FDA BLA · BLA761204

POMBILITI ATGA

cipaglucosidase alfa-atga

Sponsor: AMICUS THERAP US

APPLICATION
BLA761204
TYPE
BLA
ORIGINAL APPROVAL
2023-09-28
LATEST ACTION
2024-07-25
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

POMBILITIPrescription
CIPAGLUCOSIDASE ALFA-ATGA 105MG · INJECTABLE · INJECTION

Approval history

2024-07-25Labeling · Supplement 4 · standard — Letter ↗AP
2023-09-28Type 1 - New Molecular Entity · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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