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Baxter receives approval for bacterial infection drug

Baxter Healthcare has been given the go ahead by the FDA to market ceftriaxone injection in a frozen, premixed form. Ceftriaxone is a generic equivalent of Roche's Rocephin, used to treat a wide range of acute bacterial infections.

Baxter’s Galaxy manufacturing process incorporates the admixture and triple filtration of the therapeutic solution, fills the flexible container in an aseptic environment, and finishes the product as a frozen IV solution. Ceftriaxone will be available from mid-September.

“Frozen ceftriaxone offers a premixed presentation that is convenient for clinicians and helps reduce the chance of medication errors by eliminating the need for manual mixing,” said David Bonderud, president of Baxter’s US Medication Delivery business. “Frozen ceftriaxone, along with other recent approvals, signifies our commitment to expanding our portfolio of ready-to-use drugs, particularly with innovative packaging solutions.”

Ceftriaxone is indicated for the treatment of susceptible bacterial infections in the lung, skin, abdomen, genitourinary tract, ear, blood, central nervous system, bone and joint. It is also indicated for surgical prophylaxis.