← FDA DRUG APPROVALS

FDA NDA · NDA210251

BIKTARVY

bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate

Sponsor: GILEAD SCIENCES INC

APPLICATION
NDA210251
TYPE
NDA
ORIGINAL APPROVAL
2018-02-07
LATEST ACTION
2026-05-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

BIKTARVY · ReferencePrescription
BICTEGRAVIR SODIUM EQ 50MG BASE, EMTRICITABINE 200MG, TENOFOVIR ALAFENAMIDE FUMARATE EQ 25MG BASE · TABLET · ORAL
BIKTARVY · ReferencePrescription
BICTEGRAVIR SODIUM EQ 30MG BASE, EMTRICITABINE 120MG, TENOFOVIR ALAFENAMIDE FUMARATE EQ 15MG BASE · TABLET · ORAL

Approval history

2026-05-21Manufacturing (CMC) · Supplement 26 · standard — Letter ↗AP
2025-07-30Efficacy · Supplement 23 · standard — Label ↗AP
2024-10-08Manufacturing (CMC) · Supplement 20 · standard — Label ↗AP
2024-04-24Efficacy · Supplement 19 · priority — Letter ↗AP
2024-02-23Efficacy · Supplement 18 · standard — Label ↗AP
2023-05-01Labeling · Supplement 17 · standard — Label ↗AP
2022-10-14Efficacy · Supplement 15 · standard — Letter ↗AP
2021-10-07Efficacy · Supplement 14 · priority — Letter ↗AP
2021-09-10Labeling · Supplement 13 · standard — Label ↗AP
2021-03-04Labeling · Supplement 10 · standard — Letter ↗AP
2021-02-24Efficacy · Supplement 8 · standard — Letter ↗AP
2021-02-11Labeling · Supplement 9 · standard — Letter ↗AP
2021-02-05Efficacy · Supplement 7 · standard — Label ↗AP
2019-08-02Labeling · Supplement 6 · standard — Label ↗AP
2019-06-18Efficacy · Supplement 5 · priority — Letter ↗AP
2018-02-07Type 1 - New Molecular Entity and Type 4 - New Combination · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →