Abbott Submits Application to FDA for New Formulation of Kaletra
Abbott has submitted a supplemental new drug application to the FDA for the approval of a new, more convenient tablet formulation of its protease inhibitor Kaletra.
The tablet was developed using a proprietary novel melt-extrusion technology intended to allow patients to take fewer tablets per dose as part of their treatment regimen. In addition, the tablet would not require refrigeration, as the current soft-gel capsule formulation does.
Kaletra (lopinavir/ritonavir) has been the leading protease inhibitor for the treatment of HIV in the U.S. since 2002 and is the only protease inhibitor listed as preferred for initial therapy in the "Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents," developed by a panel convened by the HHS, the company said.