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Published on 14 November 2007

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FDA approves lower-strength Kaletra

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Pharmaceutical firm Abbott has announced that it has received Food and Drug Administration (FDA) approval for a new lower-strength tablet version of Kaletra (lopinavir/ritonavir).

The firm said that the new Kaletra tablets, which have specifically been designed to treat children with HIV, will be available in the US later this month.

The drug, which is an HIV protease inhibitor, is also marketed as Aluvia (lopinavir/ritonavir) in developing countries.

Abbott said that it is now waiting to receive marketing authorisation for the lower-strength tablets from the European Medicines Agency (EMEA).

The group said that if the EMEA rules in its favour, it intends to register the new formulation in more than 150 countries.

The original tablets are already available in 93 countries, and Abbott hopes it will also gain approval in an additional 45 territories.

Scott Brun, divisional vice president of infectious diseases and renal development at Abbott, said: “HIV/AIDS continues to have a devastating impact globally, especially among the more than two million children living with the disease throughout the world.

“Abbott developed a lower-strength tablet formulation of Kaletra to give physicians an innovative treatment option to help curb the impact of HIV infection in children.”

Copyright © PA Business 2007

Abbott



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