FDA Approves Hikma’s TYZAVAN™, a Ready-to-Infuse Vancomycin Antibiotic Delivery For Sepsis Care

Hikma Pharmaceuticals has announced U.S. FDA approval of TYZAVAN™ (Vancomycin Injection, USP), a ready-to-infuse formulation of the antibiotic vancomycin. This novel version is indicated for the treatment of serious bacterial infections, including septicemia, infective endocarditis, skin and skin structure infections, bone infections, and lower respiratory tract infections in adult and pediatric patients aged one month and older.

The outstanding feature of TYZAVAN TM is its stability at room temperature and instant availability. It does not need any thawing, reconstitution or dilution, saving preparation time to the healthcare professional and potentially quickening treatment in the case of such life-threatening conditions as sepsis, where each minute is counted.

“The approval of TYZAVANTM underscores our team’s exceptional R&D capabilities in developing innovative healthcare solutions that enhance patient care, particularly in time-sensitive situations. TYZAVANTM, 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 TYZAVANTM, ensuring its successful introduction and adoption in US hospitals,” said Dr Bill Larkins, President of Hikma Injectables.  

The approval comes at a time when rapid response to infections is vital. Sepsis, one of the targeted conditions, affects someone in the U.S. every 20 seconds, and survival rates drop sharply with delays in antibiotic administration. TYZAVAN™ aims to address this by enabling faster, streamlined delivery of care in urgent settings.