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Optimer Dificid FDA Approval for C. Diff Hinges on How to Describe Lasting Effect

This article was originally published in RPM Report

Executive Summary

Optimer’s Dificid (fidaxomicin) oral tablets for C. difficile received a strong endorsement from the Food & Drug Administration’s Anti-Infective Drugs Advisory Committee on April 5. Final approval of Optimer’s application awaits resolution of labeling language regarding the drug’s ability to deter recurrence of C. difficile infections. The drug has an initial (priority review) PDUFA date of May 30.
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