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Actavis Avycaz Approval Shows How FDA Handles Limited-Data, Limited-Use Antibiotic

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA grants approval to two of three indications for gram-negative antibiotic based on Phase II data, but follows it advisors in rejecting a third indication that came without human data, offering hints of what the limitations and possibilities of a formal limited population antibiotic approval pathway might be.


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