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U.S. FDA Approves Lower-Strength Kaletra(R) (lopinavir/ritonavir) Tablet for Pediatric HIV Patients ABBOTT PARK, IL -- November 15, 2007 -- The U.S. Food and Drug Administration (FDA) has approved a new lower-strength tablet formulation of the HIV protease inhibitor, Kaletra(R) (lopinavir/ritonavir), which is also marketed as Aluvia(R) (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. The tablets do not require refrigeration and can be taken with or without a meal -- an important advance in delivering HIV medicine to children in developing countries. The World Health Organization (WHO) estimates 2 million children were living with HIV/AIDS in sub-Saharan Africa at the end of 2006. The new lower-strength tablets are smaller in size than original Kaletra tablets and contain the same proven active ingredients as Abbott's Kaletra oral solution. The lower-strength Kaletra tablet is approved for children weighing 15kg or more who are able to swallow the intact tablet. The price of the recently approved lower-strength tablet will be half the price of the original tablet in the developing world. The new tablet formulation will complement Kaletra oral solution, which has been available for pediatric use since its approval in September 2000 in the United States. For pediatric patients, lower-strength Kaletra tablets will offer more dosing flexibility and contains 100mg of lopinavir and 25mg of ritonavir, compared with the original tablet strength of 200mg of lopinavir and 50mg of ritonavir, most commonly used by adults. SOURCE: Abbott E-mail this page to a friend or colleague! To print, use this version