Abbott laboratories gets tablet formulation of Kaletra approved

The US Food and Drug Administration (FDA) has given approval for Abbott Laboratories new tablet formulation of its HIV protease inhibitor (PI) Kaletra.

Kaletra, a combination of to medicines (lopinavir/ritonavir), was introduced in 2000 and has been taken by hundreds of thousands of patients worldwide.

The formulation is designed to allow adult HIV patients to take fewer pills with or without food as part of their treatment routine.

The FDA approval of the Kaletra tablet formulation was based on data from pharmacokinetic studies in 141 non-HIV infected, healthy individuals.

The studies demonstrated that Kaletra tablets provide similar drug levels in the blood to the capsule formulation. In these studies, Kaletra tablets were generally well tolerated.

Unlike many HIV/AIDS drugs the tablets do not need to be refrigerated before or after dispensing.

Abbott has a long history of AIDS and HIV drug and treatment development, and in 1985 developed the first licensed test to detect HIV antibodies in the blood. Abbott retroviral and hepatitis tests are used to screen more than half of the world’s donated blood supply.

Abbott recently post third-quarter earnings showing a decrease of 15 per cent from a year ago as expenses related to cost cuts offset revenue improvement.

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