Ready-to-infuse sepsis therapy marks new advancement in time-critical treatment

Hikma Pharmaceuticals, the multinational pharmaceutical company, announced the approval of a novel formulation of the first-of-its-kind, ready-to-infuse formulation of vancomycin, under the brand name TYZAVAN (Vancomycin Injection, USP), by the US Food and Drug Administration (FDA).

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: (i) septicemia; (ii) infective endocarditis; (iii) skin and skin structure infections; (iv) bone infections; and (v) lower respiratory tract infections.

The name TYZAVAN stands for “time-saving vancomycin,” reflecting its purpose: delivering timely, simplified treatment when every minute counts. TYZAVAN is the only FDA-approved vancomycin product commercially available for all patients that is available at room temperature and requires no compounding, thawing, activation or dilution—reducing preparation steps and supporting faster treatment1.

According to the Sepsis Alliance, someone in the U.S. is diagnosed with sepsis every 20 seconds, and a sepsis-related death occurs every two minutes. Sepsis is a leading cause of death and hospitalization, often requiring rapid antibiotic administration as a core part of treatment. Independent studies indicate that sepsis survival rate decreases by 15% after 87–113 minutes.

“The approval of TYZAVAN underscores our team’s exceptional R&D capabilities in developing innovative healthcare solutions that enhance patient care, particularly in time-sensitive situations,” said Dr Bill Larkins, President of Hikma Injectables. “TYZAVAN, available in ready-to-infuse aseptically filled bags, exemplifies our commitment to rethinking essential medicines by making them faster to administer, easier to manage and available when patients need them most. Our dedicated and specialised commercial team will drive the launch of TYZAVAN™, ensuring its successful introduction and adoption in US hospitals.”

TYZAVAN provides hospitals with a practical and scalable solution for improving time to treatment and reducing preparation complexity: 

  • Ready-to-infuse formulation – removes the need for on-site preparation and IV compounding, reduces strain on pharmacy and nursing staff, minimizes handling risk and reduces risk of medication errors
  • Seven presentations (0.5g–2g) – supporting flexibility for fixed and weight-based dosing
  • Room-temperature stability – shelf life of 16 months; no refrigeration needed
  • Automated dispensing cabinet compatible – seamlessly fits into hospital workflows

According to IQVIA, US sales of vancomycin injection were close to $200 million in 2024.

This product has been approved for marketing in the United States by the US FDA. This product approval does not confer the right on Hikma, or any other party, to market this product outside the United States.

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Source – PR Newswire