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US FDA approves Baxter and Water Street’s Cefazolin injection 2gm for preoperative prophylaxis

US-based Baxter International and Water Street Healthcare Partners’s Cefazolin Injection in Galaxy container (2g/100mL) has received approval from the US Food and Drug Administration (FDA).

Said to be the first product approved through the partnership, Cefazolin injection is a cephalosporin antibacterial indicated for preoperative prophylaxis treatment.

Galaxy is Baxter’s flexible container that makes use of the company’s proprietary aseptic filling manufacturing processes.

Cefazolin can also be used for preoperative prevention to help reduce the incidence of certain postoperative infections for high-risk patients undergoing surgical procedures.

Baxter Hospital Products business president Brik Eyre said: "The availability of cefazolin 2g in an efficient, ready-to-use, flexible premix container that can improve pharmacy efficiency will provide additional supply options of an important antibiotic."

The US launch of cefazolin injection 2g frozen premix in its galaxy container is expected to take place in the fourth quarter of 2015.

As part of Baxter’s development partnership with Water Street company Celerity Pharmaceuticals, the injection is the first of nine molecules actively under development to provide healthcare providers needed injectable formulations of essential drugs frequently used in critical care settings.

Eyre added: "Baxter’s innovative development partnership with Water Street allows us to accelerate product development and offers healthcare providers additional options for critical care medications produced with our proprietary manufacturing capabilities and in our container technology."