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Symtuza FDA Approval History

FDA Approved: Yes (First approved July 17, 2018)
Brand name: Symtuza
Generic name: cobicistat, darunavir, emtricitabine and tenofovir alafenamide
Dosage form: Tablets
Company: Janssen Pharmaceuticals, Inc.
Treatment for: HIV Infection

Symtuza (darunavir, cobicistat, emtricitabine and tenofovir alafenamide) is a once daily, single-tablet regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) in treatment-naïve and certain virologically suppressed adults.

Development timeline for Symtuza

Jul 17, 2018Approval FDA Approves Symtuza (D/C/F/TAF), the First and Only Complete Darunavir-Based Single-Tablet Regimen for the Treatment of HIV-1 Infection
Sep 25, 2017Janssen Submits NDA to U.S. FDA for the First Darunavir-Based Single Tablet Regimen for the Treatment of HIV-1

Further information

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