Abbott Receives FDA Approval For Lower-Dose Of Antiretroviral Kaletra For Children

Main Category: HIV / AIDS
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 14 Nov 2007 - 10:00 PDT

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Abbott Laboratories on Monday announced that it has received FDA approval to market and sell a lower-dose version of its antiretroviral drug Kaletra for children, the Chicago Sun-Times reports (Knowles, Chicago Sun-Times, 11/13). The tablet will be available in the U.S. this month, Bloomberg/Chicago Tribune reports. Kaletra has been available in liquid form for children since 2000, but the company in August warned health care providers to be cautious in prescribing Kaletra to children after the death of an infant who received an accidental overdose of the drug, Bloomberg/Chicago Tribune reports.

The new, lower-dose tablets can be taken with or without food and do not require refrigeration, which is an important advantage in treating children in developing countries, Abbott said. The new tablet will cost $2,100 annually per patient in the U.S. and $250 per patient annually in developing countries, the company said. The company added that approval in the European Union is pending, and once approved, it intends to make the drug available in more than 150 countries.

"We are expecting" the first step toward approval in the E.U. soon, Julie Herlocker, a spokesperson for Abbott, said, adding the company has an agreement with European regulators to ship the drug if it is requested directly by medical personnel (Bloomberg/Chicago Tribune, 11/13).

"HIV/AIDS continues to have a devastating impact globally, especially among the more than two million children living with the disease throughout the world," Scott Brun, divisional vice president for infectious disease development at Abbott, said, adding, "Abbott developed a lower-strength tablet formulation of Kaletra to give physicians an innovative treatment option to help curb the impact of HIV infection in children" (Abbott release, 11/12).

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