AMOXIL
LOE ApproachingNDAORALFOR SUSPENSIONPriority Review
Approved
Jan 1974
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
Priority Review
AMOXIL by GSK is drug. Approved for the treatment of infections due to susceptible (only β-lactamase–negative) isolates of the designated bacteria in the conditions listed below: 1. First approved in 1974.
Drug data last refreshed 17h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AMOXIL (amoxicillin) is an oral beta-lactam antibiotic that treats bacterial infections including ear, nose, throat, urinary tract, skin, and respiratory tract infections. It works by inhibiting bacterial cell wall biosynthesis, leading to bactericidal activity against susceptible gram-positive and gram-negative organisms. The drug is stable in gastric acid and rapidly absorbed orally, achieving therapeutic levels in most body tissues within 1-2 hours.
Post-LOE
As a mature, genericized product approaching loss of exclusivity, AMOXIL brand team is focused on lifecycle management and off-patent optimization with minimal growth investments.
Mechanism of Action
drug. [see Microbiology (12.4)]. 12.3 Pharmacokinetics Absorption: Amoxicillin is stable in the presence of gastric acid and is rapidly absorbed after oral administration. The effect of food on the absorption of Amoxicillin from the tablets and suspension of Amoxicillin has been partially…
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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.