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Abbott's Kaletra(R) and Aluvia(R) (lopinavir/ritonavir) New Lower-Strength Tablet for Pediatric Use Receives Positive Opinion from EMEA
Date:1/28/2008

Lopinavir/ritonavir tablet is the first and only co-formulated protease

inhibitor tablet approved for use in children with HIV

ABBOTT PARK, Ill., Jan. 28 /PRNewswire/ -- Abbott (NYSE: ABT) announced today that the European Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA), has issued a positive opinion recommending approval of a new, lower-strength tablet formulation of the company's leading HIV protease inhibitor, Kaletra(R) (lopinavir/ritonavir). In addition, the CHMP has adopted a positive opinion, in coordination with the World Health Organization (WHO), for Aluvia(R) (lopinavir/ritonavir), the tradename of the same lower-strength tablet formulation in developing countries.

The new lower-strength formulation is suitable for pediatric use and represents a significant breakthrough for clinicians and patients in developing countries, where more than 2 million of the estimated 2.3 million children worldwide with HIV/AIDS live. The first and only co-formulated protease inhibitor tablet that can be used in children, the tablets do not require refrigeration and can be taken with or without a meal -- an important advance in delivering HIV medicine in developing countries.

"EMEA approval is an essential first step to registering the tablet in Europe and most developing countries and it is welcome news for physicians and caregivers of children with HIV," said Mark Kline, M.D., professor of pediatrics, chief of Retrovirology, director, AIDS International Training and Research Program, and director, Baylor-CDC Global AIDS Technical Assistance Project, Baylor College of Medicine. "The development of this product, which does not require refrigeratio
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