EC approves new pediatric formulation of Kaletra

April 10, 2008

Abbott's lower-strength pediatric tablet formulation of the HIV protease inhibitor Kaletra has received marketing approval by the European Commission.

Abbott's lower-strength pediatric tablet formulation of the HIV protease inhibitor Kaletra has received marketing approval by the European Commission.

Kaletra is indicated for the treatment of HIV-1 infected adults and children over the age of 2, and is used in combination with other antiretroviral agents. The lower-strength tablet improves dosing convenience for HIV-positive children without compromising efficacy.

For example, Kaletra's soft gel capsule formulation required accompanying food intake, while the oral solution needed refrigeration. The new version requires neither food intake nor refrigeration, and contains lower doses of the active ingredient than the adult formulation.