Aurobindo gets tentative nod for anti-HIV drug

Aurobindo Pharma Ltd, a Hyderabad-based manufacturer of generic pharmaceuticals and active pharmaceutical ingredients (APIs), has received tentative approval for Lopinavir/Ritonavir tablets in 100/25mg and 200/50mg from the US Food and Drug Administration (US FDA).

With this abbreviated new drug application (ANDA), which was reviewed under the expedited provisions of the President’s Emergency Plan for AIDS Relief (PEPFAR), the Hyderabad-based company now has 93 ANDA approvals from the FDA, including 66 final approvals.

Lopinavir/Ritonavir tablets is the generic equivalent of Abbott Laboratories’ Kaletra tablets and falls under the anti-retroviral (ARV) segment, which is indicated in combination with other ARV agents for the treatment of HIV-I infections in adults and children above the age of two years. This is the first generic product tentatively approved under the PEPFAR for Abbott’s Kaletra, Aurobindo stated in a press release on Thursday.