Application Nr Approved Date Route Status External Links
NDA207501 None Intravenous None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Cresemba ® Is An Azole Antifungal Indicated For Use In The Treatment Of: • Invasive Aspergillosis. ( 1.1 ) • Invasive Mucormycosis. ( 1.2 ) 1.1 Invasive Aspergillosis Cresemba ® Is An Azole Antifungal Indicated For Patients 18 Years Of Age And Older For The Treatment Of Invasive Aspergillosis [See Clinical Studies ( 14.1 ) And Clinical Pharmacology ( 12.4 )] . 1.2 Invasive Mucormycosis Cresemba Is An Azole Antifungal Indicated For Patients 18 Years Of Age And Older For The Treatment Of Invasive Mucormycosis [See Clinical Studies ( 14.2 ) And Clinical Pharmacology ( 12.4 )] . 1.3 Usage Specimens For Fungal Culture And Other Relevant Laboratory Studies (Including Histopathology) To Isolate And Identify Causative Organism(S) Should Be Obtained Prior To Initiating Antifungal Therapy. Therapy May Be Instituted Before The Results Of The Cultures And Other Laboratory Studies Are Known. However, Once These Results Become Available, Antifungal Therapy Should Be Adjusted Accordingly.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Isavuconazonium Sulfate ISAVUCONAZONIUM SULFATE ZINC49637509

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