FDA approves generic AIDS drug
The U.S. Food and Drug Administration has given tentative approval for a generic version of the AIDS drug Viread.
The approval means that generic tablets of tenofovir disoproxil fumarate can be considered for purchase under the President's Emergency Plan for AIDS Relief (PEPFAR), a five-year, $15 billion effort to fight the HIV/AIDS pandemic, the FDA said Wednesday.
"The fight to save lives with high-quality anti-retroviral treatment is of significant importance to FDA," Gary Buehler, director of FDA's Office of Generic Drugs, said in a release. "Our scientists have been working diligently to make safe and effective treatments for AIDS available as quickly as possible to combat this worldwide problem."
The tenofovir disoproxil fumarate 300 milligram tablets are manufactured by Matrix Laboratories, LTD, of Andhra Pradesh, India.
The FDA said PEPFAR has helped provide anti-retroviral treatment for a total of more than 1.3 million men, women and children in 15 focus countries in sub-Saharan Africa, Asia and the Caribbean.
Copyright 2007 by United Press International