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Pharmacia Zyvox pediatric filing

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA accepts for filing Pharmacia's pediatric sNDA for Zyvox (linezolid) for the treatment of gram-positive infections, including those caused by methicillin-resistant Staphylococcus aureus. The supplement was submitted June 24 and will receive priority review, establishing a user fee review goal around Christmas. Zyvox was approved for adult use April 18, 2000, for treatment of vancomycin-resistant Enterococcus faecium infections, nosocomial-acquired pneumonia (including cases due to methicillin-resistant S. aureus), community-acquired pneumonia, and complicated and uncomplicated skin and skin structure infection

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