NDAINJECTIONINJECTABLE
Approved
Mar 2005
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
5
Data completeness
4/8 — Partial
MYCAMINE (micafungin sodium) by Bayer is [see microbiology (12. First approved in 2005.
Drug data last refreshed 11h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
MYCAMINE (micafungin sodium) is an echinocandin antifungal administered intravenously that inhibits fungal cell wall synthesis by targeting 1,3-beta-D-glucan synthase. It is indicated for treatment of candidemia, acute disseminated candidiasis, other Candida infections, and esophageal candidiasis, with particular utility in immunocompromised populations including HIV+ patients and hematopoietic stem cell transplant recipients. The drug demonstrates linear pharmacokinetics across therapeutic dose ranges (50–150 mg daily in adults; 1–4 mg/kg in pediatrics) with steady-state achievement by day three.
$0.249MPart D
LOE ApproachingLow commercial volume with approaching loss of exclusivity signals transition to legacy product management with minimal team expansion.
Mechanism of Action
[see Microbiology (12.4)] . 12.2 Pharmacodynamics The pharmacodynamics of micafungin related to hematogenous Candida meningoencephalitis are described in other sections of the prescribing information [see Use in Specific Populations (8.4) and Microbiology (12.4)] . 12.3 Pharmacokinetics Adults The…
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.