FDA Approves Mylan's Generic Version Of Antiretroviral Viread

Armen Hareyan's picture

Antiretroviral Drugs

Pharmaceuticalcompany Mylan on Tuesday announced that it has receivedtentative 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, calledtenofovir disoproxil fumarate, in 300-mg tablets (AP/Yahoo! Finance,12/4).


Thetentative approval for PEPFAR allows a company to immediately sell anantiretroviral in certain countries outside the U.S., ThomsonFinancial/Forbes reports. The approval also indicates that the product has achieved allsafety, efficacy and manufacturing quality standards for marketing in the U.S. (Peer, ThomsonFinancial/Forbes, 12/4).

Mylan Vice Chair and CEO Robert Coury said that the approval is "anothermilestone for Mylan and Matrix and their commitment to the company's growingantiretroviral franchise." He added, "We applaud Matrix for its highquality science and manufacturing capabilities that resulted in earning thisimportant 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 pricinginformation or international sale plans (AP/Yahoo! Finance,12/4).

Reprinted with permission from kaisernetwork.org. You can view theentire Kaiser DailyHIV/AIDS Report, search the archives, and sign up for email delivery at kaisernetwork.org/email . The Kaiser Daily HIV/AIDS Report ispublished for kaisernetwork.org, a free service of The Henry J. Kaiser FamilyFoundation.