INDIA APPROVES RANBAXY'S TRIPLE ARV FOR CHILDREN

Ranbaxy Laboratories has received approval in India to manufacture and market Triviro-LNS and Triviro-LNS DS, both triple antiretroviral (ARV) combinations, for children. The company has also filed the product with the World Health Organization for prequalification.

While Triviro-LNS contains Lamivudine 20 mg, Nevirapine 35 mg and Stavudine 5 mg, Triviro-LNS DS contains the same drugs in 40 mg, 70 mg and 10 mg strengths, respectively. The products are bioequivalent to the individual liquid formulations of the originators. The products are indicated for treatment of HIV infection in children.

While convenient, triple-fixed-dose combinations are widely available for adults, children have to largely rely on alternative options such as simultaneously taking three liquid ARV drugs or crushing solid pills to make triple drug formulations, an activity that does not deliver the three drugs in an optimal ratio. Current options make compliance to therapy difficult for children and caregivers and may increase risk of resistance or adverse effects due to noncompliance.