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Zerbaxa fda approval date?

See the DrugPatentWatch profile for Zerbaxa

What FDA approval date did Zerbaxa get?

Zerbaxa (ceftolozane and tazobactam) was approved by the U.S. FDA on February 25, 2014 [1].

Was Zerbaxa later approved for additional uses or label changes?

Yes. Zerbaxa’s FDA labeling has been updated since the initial approval, but the original FDA approval date remains February 25, 2014 [1].

What was Zerbaxa approved for when first cleared?

At the time of its initial FDA approval, Zerbaxa was indicated for the treatment of complicated intra-abdominal infections and complicated urinary tract infections (including pyelonephritis) in adults [1].

Sources:
[1] https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=204689



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