VANCOMYCIN
PeakNDAINTRAVENOUS, ORALSOLUTIONPriority Review
Approved
Aug 2021
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
5/8 — Partial
Priority Review
VANCOMYCIN by Hikma is clinical pharmacology vancomycin is poorly absorbed after oral administration. First approved in 2021.
Drug data last refreshed 49m ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Vancomycin is a glycopeptide antibiotic available in intravenous and oral formulations as a solution, used to treat serious infections caused by gram-positive bacteria including methicillin-resistant Staphylococcus aureus (MRSA). The drug works by inhibiting bacterial cell wall synthesis, making it a critical agent for severe infections where resistance to beta-lactams is present. This Hikma NDA product represents a formulation advancement in an established therapeutic class.
$0.03MPart D
Peak9.4 years to LOEThe product is in peak lifecycle stage with minimal Part D penetration, suggesting strength in institutional/hospital channels where most commercial activity and team investment likely resides.
Mechanism of Action
CLINICAL PHARMACOLOGY Vancomycin is poorly absorbed after oral administration. During multiple dosing of 250 mg every 8 hours for 7 doses, fecal concentrations of vancomycin in volunteers exceeded 100 mg/kg in the majority of samples. No blood concentrations were detected and urinary recovery did…
Indications
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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.