Abbott Laboratories has receives US FDA approval for New Lower-Strength Kaletra(R) (lopinavir/ritonavir) Tablet for Pediatric HIV Patients
Abbott laboratories has received U.S. Food and Drug Administration (FDA) approval for a new lower-strength tablet formulation of its leading HIV protease inhibitor, Kaletra(R) (lopinavir/ritonavir), which is also marketed as Aluvia(R) (lopinavir/ritonavir) in developing countries. The lower-strength Kaletra tablets will be available in the U.S. this month.
The new tablet formulation will complement Kaletra oral solution, which has been available for pediatric use since its approval in September 2000 in the United States. For pediatric patients, lower-strength Kaletra tablets will offer more dosing flexibility and contains 100mg of lopinavir and 25mg of ritonavir, compared with the original tablet strength of 200mg of lopinavir and 50mg of ritonavir, most commonly used by adults.
Abbott is awaiting EMEA marketing authorization for the Kaletra/Aluvia lower-strength tablets. Upon EMEA marketing authorization, Abbott intends to register this new tablet formulation in more than 150 countries. The soft gel capsule formulation of LPV/r is the most widely registered protease inhibitor in the world. The original tablet formulation is already available in 93 countries and Abbott is awaiting approval in an additional 45 countries for this formulation.
Approval of this lower-strength Kaletra tablet represents an important step in Abbott's ongoing commitment to the global fight against HIV because:
"HIV/AIDS continues to have a devastating impact globally, especially among the more than two million children living with the disease throughout the world," said Scott Brun, M.D., divisional vice president, infectious diseases and renal development, Global Pharmaceutical Research and Development, Abbott. "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."
The price of the recently approved lower-strength tablet will be half the price of the original tablet in the developing world.