Pharmaceutical Business review

Abbott’s pediatric HIV drug receives FDA approval

The lower-strength Kaletra tablets will be available in the US from November.

Approval of this lower-strength Kaletra tablet represents an important step in Abbott’s ongoing commitment to the global fight against HIV because these tablets do not require refrigeration and can be taken with or without a meal.

The new lower-strength tablets are smaller in size than original Kaletra tablets and contain the same proven active ingredients as Abbott’s Kaletra oral solution. The lower-strength Kaletra tablet is approved for children weighing 15kg or more who are able to swallow the intact tablet.

Scott Brun, divisional vice president, infectious diseases and renal development, global pharmaceutical R&D, Abbott, said: “HIV/AIDS continues to have a devastating impact globally, especially among the more than two million children living with the disease throughout the world. 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.”