AEGiS-AP: Mylan Gets Tentative Generic Viread OK: Mylan Receives Special FDA Approval Through AIDS Relief Program for Generic Viread Associated PressImportant note: Information in this article was accurate in 2007. The state of the art may have changed since the publication date.
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Mylan Gets Tentative Generic Viread OK: Mylan Receives Special FDA Approval Through AIDS Relief Program for Generic Viread

Associated Press - December 4, 2007

PITTSBURGH (AP) -- Drug developer Mylan Inc. said Tuesday the Food and Drug Administration tentatively approved its generic version of Gilead Sciences Inc's Viread HIV treatment, through an emergency plan for AIDS relief.

Matrix Laboratories Ltd. will make the drug, also called Tenofovir Disoproxil Fumarate, in 300-milligram doses. Mylan owns a 71.5 percent stake in India-based Matrix.

The emergency plan allows a company to immediately sell the treatment in certain countries outside of the United States. Tentative approval means the product meets safety, effectiveness and manufacturing quality standards.

Mylan did not release pricing information or international sale plans.

Sales of Viread fell during Gilead's most recent quarter by 13 percent to $149.1 million.


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