FDA Tentatively Approves Cipla Ltd.'s Abacavir Combination Tablet For Children

The FDA has granted tentative approval for a fixed-dose combination tablet containing 60 mg abacavir sulfate and 30 mg lamivudine for the treatment of HIV in children aged 3 months and older. Children eligible for treatment with this formulation must weigh at least 5 kg. The application for the tablet — which is manufactured by Cipla Limited — was reviewed under expedited provisions in the US President’s Emergency Plan for AIDS Relief (PEPFAR).