Abbott Receives FDA Approval For Lower-Strength Kaletra Tablet For Pediatric HIV Patients
Abbott has received FDA approval for a new lower-strength tablet formulation of its leading HIV protease inhibitor, Kaletra (lopinavir/ritonavir), which is also marketed as Aluvia (lopinavir/ritonavir) in developing countries. The lower-strength Kaletra tablets will be available in the U.S. this month.
Abbott is awaiting EMEA marketing authorization for the Kaletra/Aluvia lower-strength tablets. Upon EMEA marketing authorization, Abbott intends to register this new tablet formulation in more than 150 countries. The soft gel capsule formulation of LPV/r is the most widely registered protease inhibitor in the world. The original tablet formulation is already available in 93 countries and Abbott is awaiting approval in an additional 45 countries for this formulation.
Approval of this lower-strength Kaletra tablet represents an important step in Abbott's ongoing commitment to the global fight against HIV because: