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Treats Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses. Sold as Mycamine, Micafungin, Micafungin In Sodium Chloride 0.9%. Every FDA application for this active ingredient: 5 branded and 12 generic.
As of Nov 15, 2026, FDA lists 17 applications for Micafungin Sodium (sold as Mycamine, Micafungin, Micafungin In Sodium Chloride 0.9%), first approved Mar 16, 2005, with 3 new uses approved and 1 published complete response letter.
First approved: Mar 16, 2005
Applications: 17
New uses approved: 3
Complete response letters: 1
Medicare spending, 2025: $8.1M
First approved in the EU: Apr 25, 2008
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
Micafungin
Part D
$7.9M
+20%
5,248
Micafungin (J2248)
Part B
$120K
-53%
273
Mycamine
Part D
$25K
-75%
11
Micafungin (J2247)
Part B
$5K
-77%
16
Approvals in the EU (EMA)
First approved in the EU 37 months after the US. Centrally authorised medicines, matched by ingredient; see all EU approvals
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient.Drugs@FDA
Astellas
Fresenius Kabi USA
Apotex
Hikma
Zydus Pharms
Baxter Hlthcare Corp