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 22h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AmBisome is a liposomal formulation of amphotericin B, a small-molecule antifungal agent approved in 1997 for treatment of serious fungal infections in immunocompromised patients. The liposomal delivery system reduces systemic toxicity while maintaining fungicidal activity against a broad spectrum of fungi. It works by binding to fungal cell membranes and disrupting cell integrity.
$0.001BPart D
LOE ApproachingProduct is in late-stage lifecycle with minimal Medicare claims (463 in 2023), indicating a mature, limited-use specialty injectable with small commercial team.
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.