FDA Grants Tentative Approval To First Generic For Antiretroviral Viread

The U.S. Food and Drug Administration has issued a tentative approval for a generic version of Viread (tenofovir disoproxil fumarate), a drug for use in combination with other antiretroviral agents in the treatment of HIV. Tentative approval means that although existing patents and/or marketing exclusivity prevent the approval of the product in the United States at this time, the product meets all of FDA’s manufacturing quality and clinical safety and efficacy requirements. [click link for full article]

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Filed under: HIV / AIDS on December 20th, 2007