Treats human immunodeficiency virus type 1 (HIV-1) infection. NDA 221443, held by Gilead Sciences Inc. Bictegravir Sodium, Lenacapavir Sodium; Lenacapavir Sodium.
As of Nov 13, 2026, NDA 221443 (Bixlenvo Sunlenca Starter Pack (Copackaged)), held by Gilead Sciences Inc, was first approved by FDA on Aug 27, 2026, with 1 approved supplement and 0 published complete response letters.
BIXLENVO SUNLENCA STARTER PACK is a co-packaged product containing BIXLENVO and SUNLENCA tablets and is indicated for the initiation of BIXLENVO, a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no known or suspected resistance to the individual components of BIXLENVO. BIXLENVO SUNLENCA STARTER PACK is a co-packaged product containing
| Aug 27, 2026 | Original applicationNew combination · Standard review | Approved | |
| Aug 27, 2026 | Supplement 1New combination · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Bixlenvo Sunlenca Starter Pack (Copackaged)EQ 75MG BASE, EQ 50MG BASE; EQ 300MG BASE · tablet;oral | Bictegravir Sodium, Lenacapavir Sodium; Lenacapavir Sodium | RxReference drug |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
