Xellia Pharmaceuticals, a global leader in the manufacturing of specialty anti-infective treatments, announced today it has received U.S. Food and Drug Administration (FDA) approval for Premixed Vancomycin Injection in a Ready-to-Use (RTU) bag in the United States market. This approval follows Qualified Infectious Disease Product (QIDP) designation from the FDA in February 2018.
In 2014 we started on a journey to develop a pipeline of innovative, novel anti-infective therapies focused on unmet medical needs and centered on advanced formulation improvements for marketed drugs from our core portfolio. This first approval is a significant milestone for Xellia and an important validation of our strategy,
said Carl-Åke Carlsson,
It is a testament to our science, formulation and medical expertise that enabled us to successfully overcome the long standing industry challenge of stabilizing Vancomycin in solution at room temperature for an extended time, 16 months. We are continuing innovative R&D efforts with the goal to further broaden our portfolio of novel anti-infective therapies aimed at enhancing patient care and improving convenience and ease of use for healthcare professionals,
said Dr. Aleksandar Danilovski,
Vancomycin is a critical World Health Organization (WHO) designated essential medicine. With this approval, US healthcare professionals will now have access to multiple presentations (500 mg in 100 mL, 1 g in 200 mL, 1.5 g in 300 mL and 2 g in 400 mL) of the first room temperature stable Vancomycin Injection Premix with 16 months of shelf life. In addition, this should move the product closer to the patients which may reduce time to delivery in urgent, emergency needs,
Craig Boyd, Xellia’s
North American President said.