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Exblifep FDA Approval History

Last updated by Judith Stewart, BPharm on March 12, 2024.

FDA Approved: Yes (First approved February 22, 2024)
Brand name: Exblifep
Generic name: cefepime and enmetazobactam
Dosage form: Injection
Company: Allecra Therapeutics
Treatment for: Urinary Tract Infection

Exblifep (cefepime and enmetazobactam) is a fourth generation cephalosporin and beta lactamase inhibitor combination for the treatment of complicated urinary tract infections (cUTIs).

Development timeline for Exblifep

DateArticle
Feb 27, 2024Approval FDA Approves Exblifep (cefepime/enmetazobactam) for the Treatment of Complicated Urinary Tract Infections
Jun 27, 2023Allecra Therapeutics Submits New Drug Application to the U.S. FDA for Exblifep for the Treatment of Complicated Urinary Tract Infections
Feb 25, 2020Allecra Therapeutics Announces Positive Top-Line Results for Phase 3 ALLIUM Clinical Trial of Exblifep for Complicated Urinary Tract Infections

Further information

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