ROCKVILLE, Md. The Food and Drug Administration has granted tentative approval to a generic version of an HIV drug, agency records show.
The FDA gave the tentative approval to Aurobindo Pharma’s lopinavir/ritonavir tablets in the 100 mg/25 mg and 200 mg/50 mg strengths. The tablets are a generic version of Abbott Labs’ Kaletra, marketed in developing countries under the name Aluvia.
Kaletra will come off patent in 2013, according to the FDA’s Orange Book.