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As of Nov 15, 2026, ANDA 206454 (Linezolid), held by Hikma, was first approved by FDA on Aug 22, 2022, with 2 approved supplements and 0 published complete response letters.
First approved: Aug 22, 2022
Review: Standard
Supplements approved: 2
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
Linezolid 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: Linezolid is not indicated for the treatment of Gram-negative infections. The safety and efficacy of linezolid 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
