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Eraxis Approval History

FDA Approved: Yes (First approved February 17, 2006)
Brand name: Eraxis
Generic name: anidulafungin
Dosage form: Injection
Company: Pfizer Inc.
Treatment for: Candidemia

Eraxis (anidulafungin) is an antifungal medicine of the echinocandin class, indicated for the treatment of candidemia and other forms of Candida infections (intra-abdominal abscess, and peritonitis) and esophageal candidiasis.

Development History and FDA Approval Process for Eraxis

DateArticle
Feb 17, 2006Approval Eraxis - Pfizer Inc - Treatment for Candidemia
Aug 18, 2005Vicuron Pharmaceuticals Files New Drug Application (NDA) for Anidulafungin for Treatment of Invasive Candidiasis/Candidemia
May 31, 2005Vicuron Pharmaceuticals Files Amendment to Anidulafungin New Drug Application (NDA) for Treatment of Esophageal Candidiasis
Sep 21, 2004Vicuron Pharmaceuticals Provides Update on Anidulafungin Regulatory Paths
May 24, 2004Vicuron Pharmaceuticals Receives Approvable Letter from FDA for Anidulafungin for the Treatment of Esophageal Candidiasis Requesting Additional Data
Jan 22, 2004Vicuron Pharmaceuticals Announces 90-Day Extension of FDA Review of Anidulafungin New Drug Application

Further information

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