FDA approved the original new drug application for BIXLENVO on August 27, 2026, sponsored by GILEAD SCIENCES. FDA’s record shows no approved efficacy supplement on the application since.
- Application
- NDA221104
- Sponsor
- GILEAD SCIENCES
- Original approval
- Review
- priority review
- Submission class
- Type 4 - New Combination
- Active ingredient
- bictegravir and lenacapavir
Browse every approval whose brand starts with B, or the complete response letters FDA has published — the applications it did not approve.
Products under this application
| Ingredient and strength | Form | Route | Marketing status |
|---|---|---|---|
| bictegravir and lenacapavir 75MG | 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.
Source: FDA’s Drugs@FDA application file, via openFDA (export 2026-09-03). Every field on this page comes from that record.
Other approvals to GILEAD SCIENCES
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