Mylan gets tentative FDA approval for generic Zyvox tablets

7/7/2008

PITTSBURGH The Food and Drug Administration has granted tentative approval to Mylan Pharmaceuticals’ application for 600 mg linezolid tablets.

The tablets are a generic version of Upjohn’s Zyvox antibiotic tablets, which had sales of about $422 million for the 12 months ended March 31, according to IMS Health data.

Mylan has 93 applications awaiting FDA approval, including 21 that may have first-to-file opportunities.

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