Ranbaxy Gets U.S. FDA Approval for Generic AIDS Drug
May 31, 2005
Ranbaxy Laboratories today became the first Indian drug company to gain regulatory approval for a generic AIDS drug to be included in the $15 billion President's Emergency Plan for AIDS Relief (PEPFAR). The U.S. Food and Drug Administration (FDA) has granted Ranbaxy tentative approval to make and market lamivudine tablets as part of the program. Ranbaxy is seeking FDA approval of four antiretrovirals so they can be included in the program. In November, Ranbaxy pulled all its AIDS drugs from the World Health Organization's list of approved drugs after finding discrepancies in tests that had been undertaken to show that the generics were the equivalents of the brand name drugs. The company has since submitted 11 antiretrovirals for WHO approval.
Aurobindo Pharma Receives Tentative FDA Approval to Produce Generic Antiretroviral Stavudine for PEPFAR
This article was provided by CDC National Prevention Information Network. It is a part of the publication CDC HIV/Hepatitis/STD/TB Prevention News Update.