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Cresemba Approval History

  • FDA approved: Yes (First approved March 6th, 2015)
  • Brand name: Cresemba
  • Generic name: isavuconazonium
  • Dosage form: Capsules and Injection
  • Company: Astellas Pharma US, Inc.
  • Treatment for: Invasive Aspergillosis; Invasive Mucormycosis

Cresemba (isavuconazonium) is an azole antifungal indicated for the treatment of invasive aspergillosis and invasive mucormycosis.

Development History and FDA Approval Process for Cresemba

DateArticle
Mar  6, 2015Approval FDA Approves Cresemba (isavuconazonium sulfate) For Fungal Infections
Jan 22, 2015Astellas Announces FDA Anti-Infective Drugs Advisory Committee Recommends Approval of Cresemba (isavuconazonium)
Nov  3, 2014Basilea reports granting of U.S. orphan drug designation to isavuconazole for the treatment of invasive candidiasis
Jul  9, 2014Astellas Submits NDA for Isavuconazole Invasive Aspergillosis and Invasive Mucormycosis

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