← FDA DRUG APPROVALS

FDA BLA · BLA761468

HEPCLUDEX

bulevirtide

Sponsor: GILEAD SCIENCES INC

APPLICATION
BLA761468
TYPE
BLA
ORIGINAL APPROVAL
2026-05-22
LATEST ACTION
2026-05-22
ROUTE
SUBCUTANEOUS, POWDER,FOR SOLUTION
DOSAGE FORM
INJECTION
MARKETING STATUS
Prescription

Products

HEPCLUDEXPrescription
BULEVIRTIDE-GMOD 8.5MG · INJECTION · POWDER,FOR SOLUTION

Approval history

2026-05-22Type 1 - New Molecular Entity · Original · priorityLetterAP
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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