Aurobindo Pharma has received tentative approval for lopinavir/ritonavir tablets 100/25mg and 200/50mg from the US Food & Drug Administration (US FDA).
Lopinavir/ritonavir tablets 100/25mg and 200/50mg is the generic equivalent of Abbott Laboratories Kaletra tablets 100/25mg and 200/50mg and fails under the Anti-Retroviral (ARV) segment. It is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and children above the age of two years. This ANDA was reviewed under the expedited provisions of the president's emergency plan for AIDS relief (PEPFAR).
This is the first generic product tentatively approved under PEPFAR for Abbott's Kaletra.
Aurobindo now has a total of 93 ANDA approvals (66 Final approvals and 27 tentative approvals) from US FDA.