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Mylan gets tentative FDA ok on generic Reyataz

This article was originally published in Scrip

Executive Summary

Mylan Laboratories' Matrix subsidiary has gained tentative approval from the US FDA for a generic version of Bristol-Myers Squibb's HIV drug Reyataz (atazanavir sulfate capsules) under the President's Emergency Plan for AIDS Relief (PEPFAR). Existing patents or exclusivity prevent its marketing in the US, but the product will be eligible for purchase outside the US in certain developing countries.



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