AMBISOME
LOE ApproachingNDAINJECTIONINJECTABLE, LIPOSOMALPriority Review
Approved
Aug 1997
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
14
Data completeness
5/8 — Partial
Priority Review
AMBISOME by Astellas is clinical pharmacology pharmacokinetics the assay used to measure amphotericin b in the serum after administration of am b isome does not distinguish amphotericin b that is complexed with the phospholipids of am b isome from amphotericin b that is uncomplexed. First approved in 1997.
Drug data last refreshed 12h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AMBISOME is a liposomal formulation of amphotericin B, a lipid-based polyene antifungal agent used to treat serious systemic fungal infections. The drug works by binding to fungal cell membrane ergosterol, disrupting membrane integrity and causing cell death. It is indicated for patients with invasive fungal infections who cannot tolerate or have failed conventional amphotericin B therapy.
$0.001BPart D
LOE ApproachingLOE approaching signals a contracting team; roles focus on maintaining market share and managing transition planning rather than growth initiatives.
Mechanism of Action
CLINICAL PHARMACOLOGY Pharmacokinetics The assay used to measure amphotericin B in the serum after administration of Am B isome does not distinguish amphotericin B that is complexed with the phospholipids of Am B isome from amphotericin B that is uncomplexed. The pharmacokinetic profile of…
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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.