VANCOMYCIN
PeakNDAINTRAVENOUS, ORALSOLUTIONPriority Review
Approved
Aug 2021
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
6/8 — Strong
Priority Review
VANCOMYCIN by Hikma is clinical pharmacology vancomycin is poorly absorbed after oral administration. Approved for serious, severe infections caused by susceptible strains of methicillin-resistant (β-lactam-resistant) staphylococci. First approved in 2021.
Drug data last refreshed 9h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Vancomycin is a glycopeptide antibiotic administered intravenously or orally that inhibits bacterial cell-wall biosynthesis and is indicated for serious and severe infections caused by methicillin-resistant Staphylococcus aureus and other susceptible gram-positive organisms. The drug works through multiple mechanisms including disruption of cell-wall synthesis, altered membrane permeability, and RNA synthesis inhibition. It is a cornerstone therapy for hospital-acquired and community-acquired infections resistant to beta-lactams.
$0.030BPart D
PeakStable
9.0 years to LOEVancomycin is at peak lifecycle with modest Part D spending, indicating mature market positioning with steady demand but limited growth opportunity.
Mechanism of Action
CLINICAL PHARMACOLOGY Vancomycin is poorly absorbed after oral administration. In subjects with normal kidney function, multiple intravenous dosing of 1 g of vancomycin (15 mg/kg) infused over 60 minutes produces mean plasma concentrations of approximately 63 mcg/mL immediately after the completion…
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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.