The European Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion recommending approval for a new tablet formulation of Abbott's Kaletra (lopinavir/ritonavir).
The company said it expects a decision on marketing approval for Kaletra, a protease inhibitor used in the treatment of people with HIV, from the European Commission (EC) within 90 days.
The new tablet formulation is intended to be more convenient than the capsule currently available. It requires fewer doses per day, does not need to be refrigerated and can be taken with or without food.
