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Ceftolozane tazobactam ema approval date?

See the DrugPatentWatch profile for Ceftolozane

When did ceftolozane/tazobactam get approved (approval date)?

Ceftolozane/tazobactam is marketed under the brand name Zerbaxa. The FDA approval date was December 27, 2014. [1]

What exactly was FDA approved on that date?

On that date, the FDA approved ceftolozane/tazobactam (Zerbaxa) for complicated urinary tract infections (cUTIs), including pyelonephritis, and complicated intra-abdominal infections (cIAIs), with dosing and use depending on the indication and patient setting. [1]

Was it the first approval, or were later indications added?

The December 27, 2014 date refers to the initial FDA approval. Subsequent approvals and label expansions were added later for additional indications/populations (separate from the original approval date). [1]

Sources

[1] https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206779



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