Ranbaxy Laboratories on Monday became the first Indian drug company to gain regulatory approval for a generic anti-HIV drug to be included in the $15 billion President's Emergency Plan for AIDS Relief. The Food and Drug Administration granted Ranbaxy tentative approval to make and market a generic version of Epivir 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 anti-HIV 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. (Reuters)