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Data updated: Mar 10, 2026

FIRVANQ KIT

VANCOMYCIN HYDROCHLORIDE
Infectious Disease Approved 2018-01-26
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
1
Indication
--
Phase 3 Trials
1
Priority Reviews
8
Years on Market

Details

Status
Prescription
First Approved
2018-01-26
Routes
ORAL
Dosage Forms
FOR SOLUTION

Companies

AZURITY
Active Ingredient: VANCOMYCIN HYDROCHLORIDE

FIRVANQ KIT Approval History

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What FIRVANQ KIT Treats

5 indications

FIRVANQ KIT is approved for 5 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Staphylococcal Endocarditis
  • Septicemia
  • Bone Infection
  • Lower Respiratory Tract Infection
  • Skin Infection
Source: FDA Label

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov β†— Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

FIRVANQ KIT FDA Label Details

Pro

Indications & Usage

FDA Label (PDF)

Vancomycin Hydrochloride for Injection, USP is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (Ξ²-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. Vancomycin Hydrochloride for Injection, USP is indicated for initial therapy when methicillin-resistant staphylococci ...

FIRVANQ KIT Patents & Exclusivity

Latest Patent: Mar 2035

Patents (40 active)

US10959947 Expires Mar 13, 2035
US10959948 Expires Mar 13, 2035
US10959949 Expires Mar 13, 2035
US11638692 Expires Mar 13, 2035
US10493028 Expires Mar 13, 2035
US10688046 Expires Mar 13, 2035
US10959946 Expires Mar 13, 2035
+ 30 more patents
Source: FDA Orange Book

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Data Sources

FDA Approval: NDA208910 β†’ Label: DailyMed β†’ Patents: FDA Orange Book β†’ Trials: ClinicalTrials.gov β†’

Data sourced from official FDA and NIH databases. Click links to verify on original sources.