NDAORALTABLETPriority Review
Approved
May 1989
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
Priority Review
MEFLOQUINE HYDROCHLORIDE (mefloquine hydrochloride) by Medica Corp is clinical pharmacology pharmacokinetics absorption: the absolute oral bioavailability of mefloquine has not been determined since an intravenous formulation is not available. Approved for mild to moderate acute malaria caused by mefloquine-susceptible strains of p. First approved in 1989.
Drug data last refreshed 6d ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Mefloquine hydrochloride is a small-molecule antimalarial agent approved in 1989 for treatment of mild to moderate acute malaria caused by mefloquine-susceptible Plasmodium strains. It acts as a blood schizonticide with activity against erythrocytic stages of malaria parasites, including chloroquine-resistant strains. The drug is administered orally and reaches peak plasma concentrations 6-24 hours post-dose.
LOE Approaching
Product is in late-stage lifecycle with approaching loss of exclusivity; commercial teams are likely focused on generic transition planning and maintaining market presence against competitive alternatives.
Mechanism of Action
CLINICAL PHARMACOLOGY Pharmacokinetics Absorption: The absolute oral bioavailability of mefloquine has not been determined since an intravenous formulation is not available. The bioavailability of the tablet formation compared with an oral solution was over 85%. The presence of food significantly…
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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.