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Tebipenem hydrobromide FDA Approval Status

FDA Approved: No
Generic name: tebipenem hydrobromide
Company: Spero Therapeutics, Inc.
Treatment for: Urinary Tract Infection

Tebipenem hydrobromide is an oral carbapenem antibiotic in development for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, caused by susceptible microorganisms.

Development timeline for tebipenem hydrobromide

DateArticle
Jun 27, 2022Spero Therapeutics Receives Complete Response Letter from U.S. Food and Drug Administration for Tebipenem HBr New Drug Application
Oct 28, 2021Spero Therapeutics Submits New Drug Application to U.S. FDA for Tebipenem HBr for the Treatment of Complicated Urinary Tract Infections including Pyelonephritis

Further information

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