NDAINJECTIONINJECTABLE, LIPID COMPLEX
Approved
Nov 1996
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
AMPHOTEC (amphotericin b) by Bristol Myers Squibb is clinical pharmacology pharmacokinetics the pharmacokinetics of amphotericin b, administered as amphotec, were studied in 51 bone marrow transplant patients with systemic fungal infections. Approved for candidiasis, cryptococcal meningitis, aspergillosis and 5 more indications. First approved in 1996.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AMPHOTEC is a lipid complex formulation of amphotericin B, a polyene antifungal antibiotic that disrupts fungal cell membrane integrity by binding to ergosterol. It treats serious systemic fungal infections including candidiasis, aspergillosis, cryptococcal meningitis, and invasive fungal disease across immunocompromised populations.
LOE Approaching
Product is approaching loss of exclusivity with declining market significance; commercial teams are typically reduced in size during LOE transition.
Mechanism of Action
CLINICAL PHARMACOLOGY Pharmacokinetics The pharmacokinetics of amphotericin B, administered as AMPHOTEC, were studied in 51 bone marrow transplant patients with systemic fungal infections. The median (range) age and weight of those patients were 32 (3 to 52) years and 69.5 (14 to 116) kg,…
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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.