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Abbott Receives U.S. Food and Drug Administration Approval for New Lower-Strength Kaletra(R) (lopinavir/ritonavir) Tablet for Pediatric HIV Patients
Date:11/12/2007

Abbott Will Register and Make the New Lower-Strength lopinavir/ritonavir Tablet Available in More Than 150 Countries to Support Broad Access for the

More Than 2 Million Children Living with HIV Worldwide

ABBOTT PARK, Ill., Nov. 12 /PRNewswire-FirstCall/ -- Abbott today announced that it has received U.S. Food and Drug Administration (FDA) approval for a new lower-strength tablet formulation of its leading 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.

Approval of this lower-strength Kaletra tablet represents an important step in Abbott's ongoing commitment to the global fight against HIV because:

-- 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 FDA approval e
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SOURCE Abbott
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