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As of Nov 14, 2026, NDA 21132 (Zyvox), held by Pfizer, was first approved by FDA on Apr 18, 2000, with 35 approved supplements and 0 published complete response letters.
First approved: Apr 18, 2000
Review: Priority
Supplements approved: 35
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
ZYVOX is an oxazolidinone-class antibacterial indicated in adults and children for the treatment of the following infections caused by susceptible Gram-positive bacteria: Nosocomial pneumonia; Community-acquired pneumonia; Complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis; Uncomplicated skin and skin structure infections; Vancomycin-resistant Enterococcus faecium infections. Limitations of Use:
ZYVOX is not indicated for the treatment of Gram-negative infections.
The safety and efficacy of ZYVOX formulations given for longer than 28 days have not been evaluated in controlled clinical trials.
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters.Drugs@FDA and FDA complete response letters
