NDAINTRAVENOUSPOWDER
Approved
Jul 2018
Lifecycle
Peak
Competitive Pressure
30/100
Data completeness
2/8 — Basic
VANCOMYCIN HYDROCHLORIDE (vancomycin hydrochloride) by Viatris is clinical pharmacology vancomycin is poorly absorbed after oral administration. First approved in 2018.
Drug data last refreshed 9h ago · AI intelligence enriched Yesterday
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Vancomycin hydrochloride is a glycopeptide antibiotic administered intravenously as a powder for reconstitution. It treats serious gram-positive bacterial infections, including methicillin-resistant Staphylococcus aureus (MRSA), by inhibiting bacterial cell-wall biosynthesis and altering cell-membrane permeability and RNA synthesis.
Peak
Peak-stage product with established market position; commercial teams focus on market maintenance and optimization rather than growth expansion.
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.