ZAGREB, March 6, 2019 - The U.S. Food and Drug Agency (FDA) has approved the use of Croatian antibiotics intended for treating dangerous hospital infections, discovered in the Zagreb based company Xellia Pharmaceuticals, the company officials said in a press release.
Xellia Pharmaceuticals’ Premixed Vancomycin Injection in a Ready-to-Use (RTU) bag, is a glycopeptide antibacterial indicated in adult and paediatric patients, age 1 month and older, for the treatment of septicaemia, infective endocarditis, skin and skin structure infections, bone infections and lower respiratory tract infections.
Vancomycin Injection RTU is provided as a premixed solution in single-dose flexible bags, stable at room temperature (up to 25 °C) for 16 months.
The patent holder for the medicine are Zageb scientists Ivona Jasprica and Katarina Alilović.
“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, Xellia's CSO.
The FDA’s approval for the United States market was obtained on the basis of more than 60 nonclinical experiments, including studies to confirm that the new formulation does not adversely impact the efficacy profile of the active ingredient, vancomycin.
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