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BIXLENVO

NDA · New Drug Application · Sponsor: GILEAD SCIENCES INC · Approved 2026-08-27

Drug application

FDA Application #

NDA221104

Application type

New Drug Application

Brand name

BIXLENVO

Generic name

BICTEGRAVIR/LENACAPAVIR

Active ingredients

BICTEGRAVIR SODIUM; LENACAPAVIR SODIUM

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

GILEAD SCIENCES INC

Manufacturer

Gilead Sciences, Inc.

First approval

2026-08-27

Source

Authoritative

Drugs@FDA application overview

Machine

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