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Contepo FDA Approval Status

FDA Approved: No
Brand name: Contepo
Generic name: fosfomycin
Company: Nabriva Therapeutics plc
Treatment for: Urinary Tract Infection

Contepo (fosfomycin for injection) is an investigational epoxide antibiotic in development as a first-line treatment for complicated urinary tract infections (cUTIs), including acute pyelonephritis.

Development Timeline for Contepo

DateArticle
Jun 19, 2020Nabriva Therapeutics Receives Complete Response Letter from FDA on NDA for Contepo (fosfomycin) for injection
Jan  8, 2020Nabriva Therapeutics Receives FDA Acknowledgement of New Drug Application Resubmission for Intravenous Contepo (fosfomycin) for Injection
Dec 20, 2019Nabriva Therapeutics Resubmits New Drug Application for Intravenous Contepo (fosfomycin) for Injection
Apr 30, 2019Nabriva Therapeutics Receives Complete Response Letter from FDA on NDA for Intravenous Contepo (fosfomycin) for injection
Jan  4, 2019Nabriva Therapeutics Announces Acceptance of the New Drug Application for Intravenous Contepo to Treat Complicated Urinary Tract Infections by FDA
Nov  1, 2018Nabriva Therapeutics Completes Submission of New Drug Application to U.S. Food and Drug Administration for Intravenous Contepo to Treat Complicated Urinary Tract Infections

Further information

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