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Cresemba FDA Approval History

Last updated by Judith Stewart, BPharm on Dec 19, 2023.

FDA Approved: Yes (First approved March 6, 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 timeline for Cresemba

DateArticle
Dec  8, 2023Approval FDA Approves Expanded Use of Cresemba (isavuconazonium sulfate) in Children with Invasive Aspergillosis and Invasive Mucormycosis
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

See also

Cresemba (isavuconazonium) Consumer information

Further information

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