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news.The US Food and Drug Administration (FDA) has granted approval for Hikma's Tyzavan (Vancomycin Injection, USP), a ready-to-infuse vancomycin formulation.
The injection can be used directly from room temperature storage. Credit: Mufid Majnun on Unsplash.
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Tyzavan is indicated for the treatment of several serious infections in adults and children one month and above, including septicemia, infective endocarditis, skin and skin structure infections, bone infections, and lower respiratory tract infections.
This new vancomycin is the only FDA-approved product that can be used directly from room temperature storage, eliminating the need for compounding, thawing, activation, or dilution. This innovation aims to expedite treatment by reducing preparation steps.
Hikma Injectables president Dr Bill Larkins said: “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.
“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’s ready-to-infuse feature is expected to alleviate the workload on pharmacy and nursing staff, reduce handling risks, and decrease the likelihood of medication errors. The product comes in seven different presentations, ranging from 0.5g to 2g, to accommodate fixed and weight-based dosing.
With a shelf life of 16 months without the need for refrigeration, Tyzavan offers practical benefits for hospital storage. Its compatibility with automated dispensing cabinets further integrates it into existing hospital workflows.
In June this year, Hikma Pharmaceuticals USA announced an investment of $1bn by 2030 to further expand its US manufacturing and R&D capabilities.
