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In Brief: Roche's Megalone

Executive Summary

Roche's Megalone: NDA for fleroxacin has been withdrawn based on an assessment of the quinolone market. In March 1994, FDA's Anti-Infective Drugs Advisory Committee recommended approval for Megalone as a 400 mg one-dose treatment for uncomplicated gonorrhea, as first-line therapy for uncomplicated urinary tract infections, and as second-line for complicated UTI. Roche filed the NDA in December 1992...



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