New and Improved Tenofovir Combination Submitted for FDA Approval

April 10, 2015

On April 7, Gilead submitted a new drug application to the U.S. Food and Drug Administration (FDA) seeking approval for emtricitabine/tenofovir alafenamide, at two fixed doses (200/10 mg and 200/25 mg), for the treatment of HIV in adults and children over 12.

The new drug is a reformulation of tenofovir/emtricitabine (Truvada), which includes the older version of tenofovir (Viread).

The newer tenofovir, tenofovir alafenamide (TAF), has been shown to be more potent at lower doses and gentler on the bones and kidneys.

This is the second application by Gilead for a drug containing TAF. In November 2014, the manufacturer submitted an application for a reformulation of elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), which included TAF.

Read the press release.

Warren Tong is the senior science editor for and

Follow Warren on Twitter: @WarrenAtTheBody.

Copyright © 2015 Remedy Health Media, LLC. All rights reserved.

This article was provided by TheBodyPRO.


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