NDAORALCAPSULE
Approved
Apr 1986
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
2/8 — Basic
VANCOCIN HYDROCHLORIDE (vancomycin hydrochloride) by ANI Pharmaceuticals is clinical pharmacology vancomycin is poorly absorbed after oral administration. First approved in 1986.
Drug data last refreshed 9h ago · AI intelligence enriched 12h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Vancomycin hydrochloride is a glycopeptide antibiotic administered orally as a capsule, primarily used to treat Clostridioides difficile infection and other serious gram-positive bacterial infections. It works by inhibiting bacterial cell-wall biosynthesis and altering cell membrane permeability and RNA synthesis. The drug is bactericidal with no cross-resistance to other antibiotic classes.
LOE Approaching
As an off-patent antibiotic nearing end-of-life, the brand team is likely focused on cost management and generic transition planning with minimal growth-stage hiring.
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.