Abbott's new Kaletra tablets approved by EC
US health care major Abbott Laboratories says that the tablet formulation of Kaletra (lopinavir/ritonavir), used in the treatment of HIV, has received marketing authorization from the European Commission.
The Kaletra tablet was filed as a line extension to the already-approved capsule version with the European Medicines Agency (EMEA) in May of last year. In addition, the drug was approved by the US Food and Drug Administration for the HIV indication in October 2005.
Abbott also said that the tablet formulation, which was developed using the proprietary Meltrex melt-extrusion technology, is a stable, solid dispersion product which comprises 200mg lopinavir and 50mg of ritonavir. Previous soft-capsule versions of the drug were composed of 133.3mg lopinavir and 33.3mg of ritonavir, and the new formulation will result in patients requiring fewer pills to maintain treatment at the correct dosage.
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