Tenofovir/FTC co-formulation expected in US by September

Gilead Sciences announced on May 17 that the US Food and Drug Administration (FDA) had granted priority review status to the New Drug Application (NDA) for the fixed dose co-formulation of the company’s anti-HIV medications tenofovir (Viread) and FTC (emtricitabine, Emtriva).

Gilead submitted its application to the FDA on March 12, 2004 and had anticipated a decision by January 12, 2005 based on a 10-month traditional review. Under priority review, the NDA will be reviewed with in six months and the action date by which the FDA will make a decision is September 12, 2004.

The proposed tablet will contain 300 mg of tenofovir and 200 mg of FTC and will be administered in combination with at least one other anti-HIV medicine. The company said that following approval of the fco-formulation, each drug would continue to be sold individually.

The full statement is at:

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