Abbott Receives FDA Approval For Lower-Dose Of Antiretroviral Kaletra

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Antiretroviral Kaletra

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 childrenafter the death of an infant who received an accidental overdose of thedrug, Bloomberg/Chicago Tribune reports.

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

"We areexpecting" the first step toward approval in the E.U. soon, JulieHerlocker, a spokesperson for Abbott, said, adding the company has anagreement with European regulators to ship the drug if it is requesteddirectly by medical personnel (Bloomberg/Chicago Tribune, 11/13).

"HIV/AIDScontinues to have a devastating impact globally, especially among themore than two million children living with the disease throughout theworld," Scott Brun, divisional vice president for infectious diseasedevelopment at Abbott, said, adding, "Abbott developed a lower-strengthtablet formulation of Kaletra to give physicians an innovativetreatment option to help curb the impact of HIV infection in children"(Abbott release, 11/12).

Reprinted with permission from kaisernetwork.org. You can view theentire Kaiser DailyHIV/AIDS Report, search the archives, and sign up for email delivery at kaisernetwork.org/email . The Kaiser Daily HIV/AIDS Report ispublished for kaisernetwork.org, a free service of The Henry J. Kaiser FamilyFoundation.

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