Application Nr Approved Date Route Status External Links
NDA207501 2015-03-06 Intravenous RX 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 (13 Total)

Name Structure Kind Function Status
1. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
2. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
3. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
4. Stearic Acid STEARIC ACID Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.
5. Hypromelloses HYPROMELLOSES Unresolved
6. Ferric Oxide Red FERRIC OXIDE RED Molecular
7. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye
8. Water WATER Molecular
9. Gellan Gum (low Acyl) GELLAN GUM (LOW ACYL) Unresolved
10. Potassium Acetate POTASSIUM ACETATE Molecular B&N-Buffer & neutralizing agent GRAS-Generally recognized as safe.
11. Shellac SHELLAC Unresolved
12. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
13. Ammonia AMMONIA Molecular

Active Ingredients ( 1 Total)

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

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