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July 3, 2006
Europe Approves New Kaletra (Reuters Health)
July 3, 2006 (Reuters Health)—Abbott Laboratories Inc. said on Monday the European Commission had approved a new formulation of its HIV protease inhibitor Kaletra (lopinavir + ritonavir) that will allow patients to take fewer pills and will not need to be refrigerated.
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.
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.
