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Data updated: Mar 10, 2026

TYZAVAN

VANCOMYCIN HYDROCHLORIDE
Infectious Disease Approved 2019-02-15
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
3
Indications
--
Phase 3 Trials
1
Priority Reviews
7
Years on Market

Details

Status
Prescription
First Approved
2019-02-15
Routes
INTRAVENOUS
Dosage Forms
SOLUTION

Companies

Hikma
Active Ingredient: VANCOMYCIN HYDROCHLORIDE

TYZAVAN Approval History

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What TYZAVAN Treats

5 indications

TYZAVAN is approved for 5 conditions since its original approval in 2019. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Septicemia
  • Infective Endocarditis
  • Skin and Skin Structure Infections
  • Bone Infections
  • Lower Respiratory Tract Infections
Source: FDA Label

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Ongoing clinical trials by development phase

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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 ↗ 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.

TYZAVAN FDA Label Details

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Indications & Usage

FDA Label (PDF)

TYZAVAN is a glycopeptide antibacterial indicated for the treatment of the following infections in adult and pediatric patients (1 month and older) for whom appropriate dosing with this formulation can be achieved: Septicemia Infective Endocarditis Skin and Skin Structure Infections Bone Infections Lower Respiratory Tract Infections To reduce the development of drug-resistant bacteria and maintain the effectiveness of TYZAVAN and other antibacterial drugs, TYZAVAN should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. 1.1 Septicemia T...

TYZAVAN Patents & Exclusivity

Latest Patent: Nov 2035

Patents (294 active)

US10188697 Expires Nov 6, 2035
US10039804 Expires Nov 6, 2035
US11517609 Expires Nov 6, 2035
US10849956 Expires Nov 6, 2035
US12161690 Expires Nov 6, 2035
US11628200 Expires Nov 6, 2035
+ 284 more patents
Source: FDA Orange Book

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Data Sources

FDA Approval: NDA211962 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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