Back grey_arrow_rt.gif
 
 
Abbott's Tablet Formulation Of Kaletra Receives Marketing Approval From European Commission
 
 
  Monday, July 03, 2006; Posted: 06:03 AM
 
(RTTNews) - Early Monday, Abbott Park, Illinois-based health care company Abbott Laboratories said that the company has received marketing authorization from the European Commission for the tablet formulation of Kaletra- lopinavir/ritonavir. The company noted that Kaletra was a new version of the protease inhibitor for the treatment of HIV. The new Kaletra tablet allows adult patients to take fewer pills with or without food as part of their treatment regimen while maintaining the same safety and efficacy, the company said. The company added that the new formulation does not require refrigeration.
 
According to Abbott, the approved tablet formulation of Kaletra is designed to offer patients new benefits not available with the current soft capsules, enhancing the dosing convenience without compromising efficacy.
 
Kaletra was developed using the proprietary Meltrex melt-extrusion technology, a formulation process resulting in a stable, solid dispersion of Kaletra, translating to fewer pills while maintaining the same amount of lopinavir and ritonavir. The company noted that a single Kaletra tablet would now be composed of 200 mg lopinavir and 50 mg ritonavir, as compared to 133.3 mg lopinavir and 33.3 mg ritonavir in the previously introduced soft capsule.
 
The company said the European Commission's approval of the tablet formulation was based on data from pharmacokinetic studies. The Kaletra tablet submission was filed as a line extension to the EMEA on May 19, 2005. Kaletra tablet was approved by the US Food and Drug Administration, or FDA, on October 31, 2005.
 
The company said it has also filed for registration of the new tablet formulation in countries in Africa, Asia and Latin America.
 
The approval had been expected following a positive opinion from a panel of EU experts in April. U.S. regulators approved the new formulation last October.
 
Kaletra is the biggest-selling of a class of HIV drugs known as protease inhibitors. It was introduced in 2000. Adults taking Kaletra can now take the pill with or without food and the number of daily pills is reduced to four tablets from six a day.
 
Abbott said the European green light would allow it to start seeking approval for the drug in developing countries, where refrigeration presents a stumbling block.
 
The Kaletra tablet allows adult patients to take fewer pills with or without food as part of their treatment regimen while maintaining the same safety and efficacy.
 
In addition, the new formulation does not require refrigeration.
 
 
 
 
  icon paper stack View Older Articles   Back to Top   www.natap.org