FDA nod for new vancomycin formulation

19 February 2019

Specialty pharma company Xellia Pharmaceuticals has received US Food and Drug Administration (FDA) approval for premixed vancomycin injection in a ready-to-use (RTU) bag.

Vancomycin is a critical World Health Organization-designated essential medicine, and the arrival of this product should help to reduce time to delivery in urgent, emergency needs, the company said.

This approval, for use in septicaemia, infective endocarditis, skin and skin structure infections, bone infections and lower respiratory tract infections, follows the granting of Qualified Infectious Disease Product (QIDP) designation for the Xellia formulation from the FDA in February 2018.

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