HIV/AIDS

Application submitted to U.S. FDA for new formulation of Kaletra

Published in Medical Letter on the CDC and FDA, July 3rd, 2005

Abbott announced that it submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for the approval of a new, more convenient tablet formulation of its protease inhibitor (PI) Kaletra (lopinavir/ritonavir).

The tablet was developed using a proprietary novel melt-extrusion technology intended to allow patients to take fewer tablets per dose as part of their treatment regimen. In addition, the tablet would not require refrigeration, as the current soft-gel capsule formulation does.

Kaletra has been the leading protease inhibitor for the treatment of HIV in the United States since 2002 and is the only protease...

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Source: Medical Letter on the CDC and FDA (2005-07-03)

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