NDAINTRAVENOUSSOLUTIONPriority Review
Approved
Feb 2019
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
4/8 — Partial
Priority Review
TYZAVAN (vancomycin) by Hikma. Approved for glycopeptide antibacterial [epc]. First approved in 2019.
Drug data last refreshed 12h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TYZAVAN is an intravenous vancomycin solution approved by the FDA in February 2019 as a glycopeptide antibacterial agent. It is indicated for treating serious infections caused by susceptible strains of methicillin-resistant Staphylococcus aureus and other gram-positive organisms. Vancomycin works by inhibiting bacterial cell wall synthesis, leading to bacterial cell death.
Peak9.4 years to LOE
TYZAVAN operates in a mature, competitive IV antibiotic market with stable demand; brand teams are typically lean, focused on hospital and institutional channel management.
Mechanism of Action
Pharmacologic Class:
Glycopeptide Antibacterial
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
STOP-CDI: Efficacy of Fecal Microbiota Transplantation vs Fidaxomicin vs Vancomycin in Treating and Preventing Relapse of Clostridioides Difficile Infection
Started Oct 2025
424 enrolled
Clostridioides Difficile InfectionClostridioides Difficile Infection RecurrenceFecal Microbiota Transplantation (FMT)+3 more
A Model for Drug Concentration Prediction of Vancomycin
Started Mar 2024
401 enrolled
Critical IllnessInfectionsDrug Use
Continuous vs. Intermittent Infusion Vancomycin
Started May 2023
37 enrolled
Vancomycin
Optimizing Vancomycin Therapy in Children
Started Dec 2022
29 enrolled
SepsisCritical IllnessInfections+1 more
Clinical Decision Support Tool for Vancomycin Dosing in Children
Started May 2022
75 enrolled
Gram-Positive Bacterial InfectionsVancomycinPharmacokinetics+1 more
Worked on TYZAVAN at Hikma? Share your interview experience or compensation data (+7 days Pro)
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.