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Xellia Pharmaceuticals has received approval for 3 additional doses of Vanco ReadyTM, a ready-to-use (RTU) vancomycin injection product.
The new doses are expected to be available in October 2020 and will be supplied in 150mL, 250mL, and 350mL premixed bags containing 750mg, 1.25g, and 1.75g of vancomycin, respectively. Vanco Ready is also available in 100mL, 200mL, 300mL, and 400mL premixed bags containing 500mg, 1g, 1.5g, and 2g of vancomycin, respectively.
Vancomycin is a glycopeptide antibacterial indicated in adult and pediatric patients (1 month and older) for the treatment of septicemia, infective endocarditis, skin and skin structure infections, bone infections and lower respiratory tract infections.
The RTU formulation is stable at room temperature (up to 25°C) with a 16-month shelf life in overwrap and 28-day shelf life outside of overwrap. The product can also be stored in automated dispensing cabinets.
“One of the uses for Vancomycin in the US is in the treatment of sepsis,” said Craig Boyd, Xellia’s North American President. “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.”
Vanco Ready carries a Boxed Warning regarding the risk of embryo-fetal toxicity. It is not recommended for use during pregnancy due to the excipients polyethylene glycol (PEG 400) and N-acetyl D-alanine (NADA), which have caused fetal malformations in animal reproduction studies. If use of vancomycin is needed during pregnancy, alternative formulations of vancomycin should be used.
For more information visit xellia.com.
Reference
Xellia Pharmaceuticals expands approved doses of Vanco ReadyTM (ready-to-use premixed vancomycin injection bags). https://www.businesswire.com/news/home/20200902005164/en/Xellia-Pharmaceuticals-Expands-Approved-Doses-VANCO-READYTM. Accessed September 2, 2020.
