Vancomycin Premix Approved
February 15, 2019 – The U.S. FDA has approved a premixed form of the antibiotic vancomycin for injection. Xellia Pharmaceuticals’ Premixed Vancomycin Injection in Ready-to-Use (RTU) bags will be available in 500mg/100mL, 1gm/200mL, 1.5gm/300mL and 2gm/400mL dosage strengths.
Premixed Vancomycin Injection is indicated to treat septicemia, infective endocarditis, skin and skin structure infections, bone infections, and lower respiratory tract infections in patients who are at least one month of age. It should only be used to treat infections strongly suspected to be caused by bacteria susceptible to the product. A black box warning cautions that there is a risk of fetal-embryo toxicity due to the presence of polyethylene glycol (PEG 400) and N-acetyl D-alanine (NADA) in the product. The product should be used only for intravenous injection, and only in patients who require the full dose contained in the RTU bag. Recommended dosing is based on individual patient factors, such as age and weight.
Launch and pricing plans have not yet been announced.