NDAORALFOR SOLUTIONPriority Review
Approved
Jan 2018
Lifecycle
Peak
Competitive Pressure
0/100
Data completeness
4/8 — Partial
Priority Review
FIRVANQ KIT (vancomycin hydrochloride) by R-Pharm US is [ see microbiology ( ) ]. First approved in 2018.
Drug data last refreshed 36m ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
FIRVANQ KIT is an oral vancomycin hydrochloride solution approved in January 2018 for treating Clostridioides difficile infection. Vancomycin is a glycopeptide antibiotic that inhibits bacterial cell wall synthesis by binding to D-Ala-D-Ala peptide precursors. The oral formulation enables direct delivery to the colon where C. difficile colonizes.
Peak8.4 years to LOE
Product is at peak sales phase with established market presence; commercial teams likely mature-sized and focused on market maintenance and reimbursement.
Mechanism of Action
[ see Microbiology ( ) ].
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Career Relevance
FIRVANQ KIT offers stable career opportunities within R-Pharm US's commercial and market access infrastructure, focused on defending market position and optimizing reimbursement in a mature peak-phase product. Roles emphasize sales execution, payer management, and clinical education rather than new indication development.
Brand ManagerRegional Sales Manager
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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.