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Biktarvy FDA Approval History

FDA Approved: Yes (First approved February 7, 2018)
Brand name: Biktarvy
Generic name: bictegravir, emtricitabine and tenofovir alafenamide
Dosage form: Tablets
Company: Gilead Sciences, Inc.
Treatment for: HIV Infection

Biktarvy (bictegravir, emtricitabine and tenofovir alafenamide) is an integrase strand transfer inhibitor and emtricitabine/tenofovir alafenamide (Descovy) combination for the treatment of HIV-1 infection in adults.

Development Timeline for Biktarvy

DateArticle
Feb  7, 2018Approval FDA Approves Biktarvy (bictegravir, emtricitabine, tenofovir alafenamide) for Treatment of HIV-1 Infection
Aug 10, 2017Gilead Announces U.S. FDA Priority Review Designation for Fixed-Dose Combination of Bictegravir, Emtricitabine and Tenofovir Alafenamide for Treatment of HIV
Jun 12, 2017Gilead Submits New Drug Application to U.S. Food and Drug Administration for Fixed-Dose Combination of Bictegravir, Emtricitabine and Tenofovir Alafenamide for HIV Treatment

Further information

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