This article was originally published in Pharmaceutical Approvals Monthly
NDA submitted for HIV/AIDS therapy lopinavir/ritonavir (ABT-378/r) June 1. The protease inhibitor combination is being reviewed for accelerated approval based on ongoing Phase II/III studies evaluating the product in combination with other antiretroviral agents, according to the company. The product is a combination of the NME lopinavir and Abbott's ritonavir, which is marketed as Norvir
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