FDA approves premixed vancomycin injection from Xellia Pharmaceuticals

Xellia Pharmaceuticals announced that the FDA has approved its premixed vancomycin injection in a ready-to-use bag.

The injection is indicated in nonpregnant patients aged 1 month or older to treat septicemia, infective endocarditis, skin and skin structure infections, bone infections and lower respiratory tract infections, Xellia noted.

“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,” Xellia Chief Scientific Officer Aleksandar Danilovski, PhD, said in a news release.

According to Xellia, the injection is provided as a premixed solution in single-dose bags and is available in solutions of 100 mL (500 mg vancomycin), 200 mL (1 g vancomycin), 300 mL (1.5 g vancomycin), and 400 mL (2 g vancomycin). Every 100 mL of solution for injection contains 1.8 mL polyethylene glycol 400, 1.36 g N-acetyl-D-alanine, and 1.26 g L-lysine hydrochloride (monochloride) in water, the company explained.

The FDA approved the novel vancomycin formulation based on more than 60 nonclinical experiments, including studies that showed the formulation does not reduce the efficacy of vancomycin, according to the release. The safety profile of the formulation was evaluated both in vitro and in vivo in five repeat-dose toxicity studies in rats and dogs with dosing up to 13 weeks in addition to other studies to determine the safety of N-acetyl-D-alanine and polyethylene glycol 400, the company said.

Xellia warned that the formulation is not recommended for pregnant women because animal reproductive studies showed that N-acetyl-D-alanine and polyethylene glycol 400 can cause fetal malformations. The use of other available formulations of vancomycin are suggested during pregnancy, the company said. – by Erin Michael

Reference:

Xellia. Xellia Pharmaceuticals receives US FDA approval for premixed vancomycin injection. Available at: https://www.xellia.com/media/press-releases-and-news-archive/xellia-pharmaceuticals-receives-us-fda-approval-for-premixed-vancomycin-injection. Accessed on February 20, 2019.

Disclosure: Danilovski is employed by Xellia.