FDA approval · Drugs@FDA
BIXLENVO SUNLENCA STARTER PACK (COPACKAGED)bictegravir sodium, lenacapavir sodium, lenacapavir sodium
NDA221443 ·
FDA approved the original new drug application for BIXLENVO SUNLENCA STARTER PACK (COPACKAGED) on August 27, 2026. Today GILEAD SCIENCES INC holds the application (Drugs@FDA). FDA’s record shows no approved efficacy supplement on the application since.
- Application
- NDA221443
- Sponsor
- GILEAD SCIENCES INCOpen the company page for GILEAD SCIENCES INC (GILD), the listed company we match this holder to.
- Original approval
- Review
- standard review
- Submission class
- Type 4 - New Combination
- Active ingredient
- bictegravir sodium, lenacapavir sodium, lenacapavir sodium
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Products under this application
| Ingredient and strength | Form | Route | Marketing status |
|---|---|---|---|
| bictegravir sodium, lenacapavir sodium EQ 75MG BASE, EQ 50MG BASE; lenacapavir sodium EQ 300MG BASE | TABLET | ORAL | Prescription |
Approved efficacy supplements
An efficacy supplement is how a sponsor asks FDA to approve a change that needs clinical evidence — most often a new indication. FDA’s record gives each one a submission number, a date and a review priority. It does not say what any supplement approved, so neither does this page. The approval letter and label for each are on accessdata.fda.gov under the application number.
FDA’s record shows no approved efficacy supplement on this application.
FDA records other approved supplements on this application, by the class code it assigns them: Type 4 - New Combination 1. Those are changes to the label or to how the drug is made rather than new clinical evidence, so they are counted here and not listed.
Source: FDA’s Drugs@FDA application file, via openFDA (export 2026-09-26). Every field on this page comes from that record.
Other applications GILEAD SCIENCES INC holds today
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