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Ranbaxy gets marketing nod for paediatric anti-retrovirals
Ranbaxy says it has received approval to market two anti-HIV combination paediatric drugs, reports Business Line. 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.
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.
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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.
