NDAINTRAVENOUS, ORALPOWDER
Approved
Jan 2023
Lifecycle
Peak
Competitive Pressure
30/100
Data completeness
2/8 — Basic
VANCOMYCIN HYDROCHLORIDE (vancomycin hydrochloride) by Inpharmus is clinical pharmacology vancomycin is poorly absorbed after oral administration. First approved in 2023.
Drug data last refreshed 3h ago · AI intelligence enriched Yesterday
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Vancomycin hydrochloride is a glycopeptide antibiotic administered intravenously or orally that inhibits bacterial cell-wall biosynthesis and alters cell-membrane permeability. It is a foundational agent for treating serious gram-positive infections, including methicillin-resistant Staphylococcus aureus (MRSA), streptococcal infections, and enterococcal disease. The drug demonstrates bactericidal activity with no cross-resistance to other antibiotic classes.
Peak
Vancomycin is at peak lifecycle as an established essential antibiotic with sustained demand, supporting stable commercial and medical affairs teams.
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.