FDA gives Matrix tentative approval for generic Viread

WASHINGTON Matrix Laboratories has received tentative approval from the Food and Drug Administration for its application for a generic version of the HIV treatment drug Viread.

The drug is used in combination with other antiretroviral agents to treat HIV. Matrix received the first approval for the generic, named tenofovir disoproxil fumarate, in 300 mg tablets.

The company’s application was approved in less than six months and is the seventh under President’s Emergency Plan for AIDS Relief in the last 12 months. Under the President’s Emergency Plan for AIDS Relief, a tentative approval means that a company can immediately sell an AIDS treatment outside of the U.S.

The goal of the program is treat 2 million people affected with the HIV virus, prevent 7 million new infections, and care for 10 million people infected by HIV/AIDS, including orphans and children. President Bush is working with congress now to reauthorize the program for another five years that would give $15 billion in support to fight the pandemic.