Tenofovir/FTC co-formulation application made to EMEA
Application for marketing approval for a new dual-nucleoside formulation of tenofovir and the recently approved FTC (emtricitabine) was made to the US and European regulatory authorities by Gilead on 15 March 2004.
Simultaneous submissions to each agency are likely to result in a decision on approval in six to nine months in both Europe and the US. Each drug is already approved as once-daily treatment.
Source: Gilead PR. Gilead submits applications to U.S. and European regulatory authorities for fixed dose co-formulation of Viread and Emtriva. (15 March 2004).