← FDA Drug Approvals (Drugs@FDA)

HIBSAGO

NDA · New Drug Application · Sponsor: GLAXOSMITHKLINE LLC · Approved 2026-10-20

Drug application

FDA Application #

NDA221276

Application type

New Drug Application

Brand name

HIBSAGO

Generic name

Bepirovirsen

Active ingredients

BEPIROVIRSEN

Dosage form

INJECTION

Route

SOLUTION

Marketing status

Prescription

Sponsor

GLAXOSMITHKLINE LLC

First approval

2026-10-20

Source

Authoritative

Drugs@FDA application overview

Machine

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