Xellia Pharmaceuticals (‘Xellia’), a global leader in the manufacturing of specialty anti-infective treatments, has received approval for 3 additional dosages of VANCO READYTM, expanding its range of room-temperature-stable, ready-to-use (RTU) Vancomycin injection premix bags
The VANCO READYTM approvals now cover all relevant doses from 500 mg to 2 g in 250 mg increments. The recent approval of 750 mg in 150 mL, 1.25 g in 250 mL and 1.75 g in 350 mL are expected to launch in October 2020 and will join the other presentations launched in 2019 – 500 mg in 100 mL, 1 g in 200 mL, 1.5 g in 300 mL and 2 g in 400 mL.
VANCO READYTM should not be administered during pregnancy, please see boxed warning below.
Carl-Åke Carlsson, Xellia’s CEO said: “With all seven VANCO READYTM presentations now approved, Xellia can service the majority of needs in the Vancomycin injection market. The success of our first four products has resulted in over 2,000 US institutions using VANCO READYTM and we expect the new codes to be quickly adopted given the positive feedback from healthcare professionals.”
He added, “Our focus continues to be to provide life-saving medicine in novel and ready forms to improve patient safety and ensure reliable supply.”
Vancomycin Injection is a glycopeptide antibacterial indicated in adult and pediatric patients (1 month and older) for the treatment of: septicaemia (sepsis), infective endocarditis, skin and skin structure infections, bone infections and lower respiratory tract infections.
Craig Boyd, Xellia’s North American President said: “One of the uses for Vancomycin in the US is in the treatment of sepsis. The timely initiation of effective antibiotic treatments is universally recognised as a key intervention in the management of this life-threatening state as well as other infections. We are pleased to have been able to expand the range of doses available to clinicians, broadening their options to aid rapid and effective treatment.”
In the US, sepsis is the third leading cause of death after heart disease and cancer, affecting more than 1.7 million people and killing more than 270,000 people within a single year.1
“Our room-temperature-stable VANCO READYTM premix has been critical in providing a truly ready Vancomycin Injection product. It aligns with recommendations from US agencies – such as the American Society of Hospital Pharmacists (ASHP), Institute for Safe Medication Practices (ISMP) and Joint Commission – to use manufacturer-prepared products as part of safe medication practice. We will continue to build on this success and focus on our ready-to-use product pipeline and partnerships during 2020.”
