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www.fdanews.com/articles/100995-fda-approves-abbott-8217-s-kaletra-for-pediatric-patients

FDA Approves Abbott’s Kaletra for Pediatric Patients

November 13, 2007

Abbott has received FDA approval for a new lower-strength tablet formulation of its leading HIV protease inhibitor, Kaletra, which is marketed as Aluvia in developing countries.

The pediatric dose of Kaletra (lopinavir/ritonavir) will offer more dosing flexibility and contain 100 mg of lopinavir and 25 mg of ritonavir compared with the original tablet strength of 200 mg of lopinavir and 50 mg of ritonavir.

The tablets will be available in the U.S. shortly. Abbott is awaiting marketing authorization from the European Medicines Agency for the tablets.

Abbott said it intends to register the formulation in more than 150 countries, and it will be available at half the cost in the developing world.