Fixed dose combination (FDC) of tenofovir/FTC/efavirenz (Atripla) filed in EU

On 9 October 2006, filing for the fixed-dose combination of tenofovir/FTC/efavirenz (Atripla) was submitted to the European regulatory authorities (Committee for Medicinal Products for Human Use (CHMP), subject to validation by the EMEA). It usually takes approximately 6 months from filing for the EMEA to approve a Marketing Authorisation Application, and for the drug to become commercially available.

This one-pill, once-daily formulation is the result of a collaboration between Gilead Sciences (manufacturers of tenofovir and FTC), Bristol-Myers Squibb, and Merck Sharp & Dohme (who hold marketing rights for efavirenz in different European countries).

The product contains 600 mg of efavirenz, a non-nucleoside reverse transcriptase inhibitor (NNRTI), 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate, both nucleoside reverse transcriptase inhibitors (NRTIs).

This FDC was approved in the US on 12 July 2006.

Source: Gilead press release

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