This product is the first tentatively approved generic version of Sustiva Tablets, manufactured by Bristol-Myers Squibb.

Efavirnez now will be available for purchase under the President's Emergency Plan for AIDS Relief (PEPFAR).

Meets Quality, Safety, Efficacy Standards

Efavirenz is in the class of drugs called "non-nucleoside reverse transcriptase inhibitors (NNRTIs)," which helps keep the AIDS virus from reproducing in cells. This antiretroviral drug is used in combination with other antiretroviral agents for the treatment of HIV-1 infection.

The agency's tentative approval means that although existing patents and/or exclusivity prevent marketing of these products in the United States, they meet all of the agency's quality, safety and efficacy standards.

Fighting the Pandemic

"HHS and this Administration are working diligently to end the suffering of those with HIV/AIDS," said Health and Human Services Secretary Mike Leavitt.

"By making these safe and effective treatments available through the PEPFAR program as quickly as possible, we are helping to combat this worldwide problem." he added.

The Emergency Plan for AIDS Relief, which President Bush first announced in his 2003 State of the Union Address, currently is providing $15 billion to fight the HIV/AIDS pandemic over five years, with a special focus on 15 of the hardest-hit countries.

Three Targets

The PEPFAR plan is designed to prevent seven million new HIV infections, treat at least two million HIV-infected people, and care for ten million HIV-affected individuals, AIDS orphans and vulnerable children.

It targets three specific areas related to HIV/AIDS: