INDIA BUSINESS WORLD - DECEMBER 1^st - DECEMBER 15^th - 2007

RANBAXY GETS USFDA NOD TO MARKET TWO ARV DRUGS

RANBAXY Laboratories has received US Food and Drug Administration's (USFDA) approval to manufacture and market two paediatric anti-retroviral (ARV) drugs, Coviro-LS kid and Coviro-LS kid DS, in the US. Both drugs are double ARV and fixed dose combination dispersible tablets. The company has also filed the products with WHO Geneva for pre-qualification, a Ranbaxy Laboratories release said.

"Ranbaxy is committed to develop innovative ARVs at affordable cost. We strongly believe that with these new formulations, we will be able to make accessible a high quality and convenient treatment to a large number of HIV-positive children who are therapeutically among the most neglected," Ranbaxy Laboratories CEO and MD Malvinder Mohan Singh said. Coviro-LS kid contains Lamivudine 20 mg and Stavudjne 5 mg, Coviro-LS kid DS contains the drugs in 40 mg and 10 mg strengths respectively. Last year, the Gurgaon-based company had launched two triple ARV combinations for children. Ranbaxy presently has 15 ARVs of the WHO pre-qualification list of which three are USFDAapproved.

Fixed dose combinations ARV drugs are widely available for adults, but children usually take multiple ARV drugs or crush and take adult triple drug formulations. Presently, there are 2.3 million HIV-positive children in developing countries and about 5 lakh of them die every year.