Xellia announced that the Food and Drug Administration (FDA) has approved its Premixed Vancomycin Injection in a Ready-to-Use bag.
Vancomycin Injection Premix is stable at room temperature (up to 25 °C) and has 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.
The approval was supported by data from over 60 non-clinical experiments, including studies to confirm that the new formulation does not negatively affect the efficacy of vancomycin. However, this formulation of vancomycin is not recommended for use during pregnancy because it contains the excipients polyethylene glycol (PEG) 400 and N-acetyl-D-alanine (NADA), which caused fetal malformations in animal reproduction studies. If use of vancomycin is needed during pregnancy, other available formulations should be used.
“With this approval, US healthcare professionals will now have access to multiple presentations (500mg in 100mL, 1g in 200mL, 1.5g in 300mL and 2g in 400mL) 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,” stated Craig Boyd, Xellia’s North American President.
Vancomycin Injection, a glycopeptide antibacterial, is indicated in adults 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.
For more information call (833) 295-6953 or visit Xellia.com.