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Aurobindo gets tentative FDA ok for lopinavir/ritonavir

This article was originally published in Scrip

Executive Summary

Aurobindo Pharma has received tentative US FDA approval for lopinavir/ritonavir tablets 100/25mg and 200/50mg, generic versions of Abbott Laboratories' antiretroviral Kaletra tablets. This is the first tentative approval of a generic version of Kaletra under PEPFAR (President's Emergency Plan for AIDS Relief). Aurobindo, which recently entered a licensing and supply deal with Pfizer for a range of generics (scripnews.com, March 4th, 2009), now has 93 ANDA approvals (66 final and 27 tentative approvals) from the FDA.

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