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Defencath FDA Approval Status

Last updated by Judith Stewart, BPharm on Dec 3, 2020.

FDA Approved: No
Brand name: Defencath
Generic name: taurolidine
Company: CorMedix Inc.
Treatment for: Prevention of Catheter Related Blood Stream Infections (CRBSI)

Defencath (taurolidine) is a synthetic broad-spectrum antimicrobial and antifungal in development for use as a catheter lock solution in hemodialysis patients for the prevention of catheter related blood stream infections (CRBSI).

Development Timeline for Defencath

Mar 28, 2022Cormedix Inc. Announces FDA Acceptance of Resubmission of New Drug Application for Defencath
Mar  1, 2021Cormedix Receives Complete Response Letter From FDA for Defencathâ„¢ Catheter Lock Solution
Nov 18, 2020CorMedix Inc. Announces FDA Decision That Advisory Committee Meeting for New Drug Application for Defencath is Not Needed
Aug 31, 2020CorMedix Inc. Announces FDA Acceptance for Filing and Priority Review of New Drug Application for Defencath
Jul  8, 2020CorMedix Inc. Reports Submission of Defencathâ„¢ New Drug Application

Further information

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