FDA Approves Premixed Vancomycin Injection

FEBRUARY 19, 2019
Officials with the FDA have approved Xellia Pharmaceuticals’ Premixed Vancomycin Injection in a Ready-to-Use (RTU) bag, according to the company.

Vancomycin is a glycopeptide antibacterial indicated in adult and pediatric patients, age 1 month and older, for the treatment of septicaemia, infective endocarditis, skin and skin structure infections, bone infections and lower respiratory tract infections.

Vancomycin Injection RTU is provided as a premixed solution in single-dose flexible bags, stable at room temperature (up to 25 °C) for 16 months.

This product is provided as 100 mL, 200 mL, 300 mL or 400 mL solution containing 500 mg, 1 g, 1.5 g or 2 g vancomycin, respectively. Each 100 mL of solution contain 1.8 mL polyethylene glycol 400, 1.36 g N-acetyl-D-alanine, and 1.26 g L-lysine hydrochloride (monochloride) in water for injection. Hydrochloric acid and sodium hydroxide are used for pH adjustment. 

“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. We are continuing innovative R&D efforts with the goal to further broaden our portfolio of novel anti-infective therapies aimed at enhancing patient care and improving convenience and ease of use for healthcare professionals.” said Dr. Aleksandar Danilovski, Xellia's CSO.

The FDA’s approval for the United States market was obtained on the basis of more than 60 nonclinical experiments, including studies to confirm that the new formulation does not adversely impact the efficacy profile of the active ingredient, vancomycin.

Common adverse reactions are anaphylaxis, ‘red man syndrome,’ acute kidney injury, hearing loss, and neutropenia, according to Xellia.

This approval follows the product’s Qualified Infectious Disease Product (QIDP) designation by the agency in February 2018. The company launched its Vancomycin Hydrochloride for Injection, USP for the United States market in November 2018.

“Vancomycin is a critical World Health Organization designated essential medicine. With this approval, US health care professionals will now have access to multiple presentations 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,” said Craig Boyd, Xellia’s North American President, in a prepared statement.

Full prescribing information for Vancomycin Injection Premix RTU can be found at www.xellia.com/us


Reference

Xellia Pharmaceuticals Receives US FDA Approval for Premixed Vancomycin Injection [news release]. Copenhagen, Denmark and Buffalo Grove, Illinois; February 19, 2019: Xellia website. https://www.xellia.com/media/press-releases-and-news-archive/xellia-pharmaceuticals-receives-us-fda-approval-for-premixed-vancomycin-injection. Accessed February 19, 2019. 

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