Ranbaxy gets approval to produce, sell anti-AIDS drug
Country's largest drug maker, Ranbaxy Laboratories Limited (RLL) on Monday said it had received approval to manufacture and market anti-AIDS/HIV drug for children 'Triviro-LNS kid' and 'Triviro-LNS kid DS' in India and also filed with WHO Geneva f...
By PTI |
NEW DELHI: Country's largest drug maker, Ranbaxy Laboratories Limited (RLL) on Monday said it had received approval to manufacture and market anti-AIDS/HIV drug for children 'Triviro-LNS kid' and 'Triviro-LNS kid DS' in India and also filed with WHO Geneva for pre-qualification for the same.
Both the products are triple anti-retroviral (ARV) combinations for children. While Triviro-LNS kid contains Lamivudine 20mg, Nevirapine 35mg, and Stavudine 5mg, Triviro-LNS kid DS contains the drugs in 40mg, 70mg and 10mg strengths respectively, the company said in a statement.
"We hope 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 presently among the therapeutically most neglected, RLL CEO and Managing Director Malvinder Mohan Singh said.
The products are bio-equivalent with the individual liquid formulations of the originators. The products are indicated for treatment of HIV infection in children, the statement added.
Both the approved formulations are scored dispersible tablets. The products are designed to deliver three ARV drugs together in recommended strengths and simplify delivery of a more accurate treatment to children in resource poor settings, it said.
While convenient triple fixed dose combinations are widely available for adults, children have so far had to largely rely on cumbersome options such as simultaneously taking three different liquid ARV drugs or crushing and taking unpalatable adult triple drug formulations, an activity that does not deliver the three drugs in a ratio that is optimal for children, the company said.
Ranbaxy presently has 12 ARVs on the WHO pre-qualification list, of which three are USFDA approved.
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