Application for meltrex formulation of Kaletra submitted to the FDA

Abbott announced today that it submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) of a new formulation of 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.

The new tablet will provide patients with a tablet composed of 200 mg lopinavir and 50 mg ritonavir, which will reduce daily pill count to 4 tablets daily (standard current dose is 6 capsules). The submission package included data from bioequivalence studies.

Source: Abbott Press Release, May 2005

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