Mylan gets tentative FDA approval for generic Zyvox tablets

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.