Mylan Gets Tentative Approval for Generic HIV Drug
Thu, 03/12/2009 - 7:49am
PITTSBURGH (AP) — Drugmaker Mylan Inc. said Thursday it received tentative U.S. approval for a generic, heat-resistant version of an Abbott Laboratories HIV drug. The Food and Drug Administration decision means Mylan's version of lopinavair and ritonavir meet safety, effectiveness and manufacturing quality standards. The drug, made by Matrix Laboratories of India, is a version of a product sold by Abbott under the name Kaletra in the U.S., and as Aluvia in the developing world. The drug is designed to be heat-stable and low-cost, making it more practical to distribute and use in countries with warm climates. The World Health Organization gave a similar approval to Mylan's drug in February, clearing the way for marketing outside of the U.S. and Europe. Abbott reported $378 million in Kaletra revenue in 2008.