FDA Tentatively Approves Mylan's Generic Version Of Antiretroviral Viread For Use In PEPFAR

Main Category: HIV / AIDS
Also Included In: Regulatory Affairs / Drug Approvals;  Pharma Industry / Biotech Industry
Article Date: 06 Dec 2007 - 10:00 PDT

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Pharmaceutical company Mylan on Tuesday announced that it has received tentative FDA approval for its generic version of Gilead Sciences' antiretroviral drug Viread for use in the President's Emergency Plan for AIDS Relief, the AP/Yahoo! Finance reports. India-based Matrix Laboratories will produce the drug, called tenofovir disoproxil fumarate, in 300-mg tablets (AP/Yahoo! Finance, 12/4). The tentative approval for PEPFAR allows a company to immediately sell an antiretroviral in certain countries outside the U.S., Thomson Financial/Forbes reports. The approval also indicates that the product has achieved all safety, efficacy and manufacturing quality standards for marketing in the U.S. (Peer, Thomson Financial/Forbes, 12/4).

Mylan Vice Chair and CEO Robert Coury said that the approval is "another milestone for Mylan and Matrix and their commitment to the company's growing antiretroviral franchise." He added, "We applaud Matrix for its high quality science and manufacturing capabilities that resulted in earning this important tentative approval in such a short time frame" (Mylan release, 12/4). Mylan owns a 71.5% stake in Matrix. The company did not announce pricing information or international sale plans (AP/Yahoo! Finance, 12/4).

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