Indian drug company Ranbaxy gains FDA approval for HIV drug

Jun 2 2005

Indian drug company Ranbaxy Laboratories has this week become the first Indian drug company to gain regulatory approval for a generic anti-HIV drug.

The drug is to be included in the $15 billion President's Emergency Plan for AIDS Relief.

Ranbaxy has been granted tentative approval by the FDA to make and market a generic version of Epivir as part of the program.

Ranbaxy is also seeking the FDA approval of four antiretrovirals so they can also be included in the program.

After finding discrepancies in tests Ranbaxy pulled all its anti-HIV drugs from the World Health Organization's (WHO) list of approved drugs in November, and undertook to show that the generic drugs were the equivalents of the brand-name drugs.

The company has since submitted 11 antiretrovirals for WHO approval.