The Hindu Business Line : Ranbaxy gets marketing nod for paediatric anti-retrovirals

New Delhi, Dec 6 Ranbaxy says it has received approval to market two anti-HIV combination paediatric drugs. Coviro-LS kid and Coviro-LS kid DS, both double Anti-Retroviral (ARV) and fixed dose combinations, dispersible tablets for children, have received manufacturing and marketing approval in the domestic market.

WHO application

The company said in a statement that it has also applied for WHO pre-qualification for the same products. While Coviro-LS kid is a combination of Lamivudine 20mg and Stavudine 5mg, Coviro-LS kid DS combines Lamivudine 40mg with Stavudine 10mg.

Ranbaxy claims the products are bio-equivalent with the individual liquid formulations of the originators. Lamivudine is sold by GSK under the brand name Epivir and EPivir-HBV, while Stavudine is marketed by Bristol Myers Squibb under the brand name Zerit.

“We 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,” said Mr Malvinder Mohan Singh, CEO and Managing Director, Ranbaxy.

The products are designed to deliver two ARV drugs together in recommended strengths and simplify delivery of a more accurate treatment to children in resource poor settings, says Ranbaxy.

Last year, the company had launched two Triple ARV combinations for children, Triviro-LNS kid and Triviro-LNS kid DS, taking its total paediatric ARVs to four.

Ranbaxy Laboratories currently has 15 ARVs on the WHO pre-qualification list, of which three have US Food and Drug Administration’s approval.

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