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Mylan's Matrix gets tentative FDA nod for HIV/AIDS treatment co-pack option.

M2 PHARMA-September 20, 2011-Mylan's Matrix gets tentative FDA nod for HIV/AIDS treatment co-pack option(C)2011 M2 COMMUNICATIONS

20 September 2011 - US Mylan Inc (NASDAQ:MYL) said today that its subsidiary Matrix Laboratories has obtained tentative US Food and Drug Administration (FDA) approval through the President's Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application (NDA) for Lamivudine / Tenofovir Disoproxil Fumarate Tablets, 300 mg/300 mg, co-packaged with Nevirapine Tablets, 200 mg.

The company added that the HIV/AIDS treatment product will be eligible for purchase outside the US in certain developing countries.

Mylan further said that this product offering is the first generic ARV drug product in a co-pack form and that it can be used alone or in combination with other ARVs for the treatment of HIV/AIDS.

Lamivudine, Tenofovir Disoproxil Fumarate and Nevirapine are the generic versions of GlaxoSmithKline's (LON:GSK) Epivir, Gilead Sciences' (NASDAQ:GILD) Viread and Boehringer Ingelheim's Viramune, respectively.

This particular co-pack of ARV products also is suitable for the treatment of pregnant women with HIV/AIDS in certain countries where Lamivudine, Tenofovir Disoproxil Fumarate and Nevirapine are approved for use during pregnancy. Nevirapine is preferred over other drugs in the same class, such as Efavirenz, for pregnant women with HIV/AIDS, Mylan said.

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Date:Sep 20, 2011
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