First generic Viread cleared by FDA

The US Food and Drug Administration has issued a tentative approval for a generic version of Viread (tenofovir disoproxil fumarate), a drug developed and sold by Gilead Sciences for use in combination with other antiretroviral agents in the treatment of HIV. This means that, although existing patents and/or marketing exclusivity prevent the approval of the product in the USA at this time, the product meets all of the FDA's manufacturing quality and clinical safety and efficacy requirements. The 300mg tenofovir tablets are manufactured by India's Matrix Laboratories.

"The fight to save lives with high-quality antiretroviral treatment is of significant importance to [the] FDA," said Gary Buehler, Director of its Office of Generic Drugs. "Our scientists have been working diligently to make safe and effective treatments for AIDS available as quickly as possible to combat this worldwide problem."

Tenofovir disoproxil fumarate is the latest addition of an antiretroviral product that can be considered for purchase under the President's Emergency Plan for AIDS Relief (PEPFAR), a five-year, $15.0 billion effort to fight the HIV/AIDS pandemic - the largest commitment ever by a single nation toward an international health initiative, the agency notes.