Baxter Healthcare Corporation announced has received approval from the US FDA for Ceftriaxone Injection, USP 1g/50 mL and 2g/50 mL packaged in single-dose plastic containers. Baxter, the only company to offer frozen premixed drugs, will add Ceftriaxone, the generic version of Roche Pharmaceuticals’ Rocephin, to its frozen portfolio. Used to treat a wide range of acute infections, the product will be available mid-September, said a company release here.
“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,” David Bonderud, president of Baxter’s US Medication Delivery business said adding, “Frozen Ceftriaxone, along with other recent approvals, signifies our commitment to expanding our portfolio of ready-to-use drugs, particularly with innovative packaging solutions.”
Baxter’s proprietary 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. “By leveraging this proprietary manufacturing platform, we’re able to offer the only frozen, premixed version of this popular antibiotic,” said Joel Tune, general manager of Baxter’s BioPharma Solutions group.
Approval for the frozen, premixed presentation follows Baxter’s July 2005 launch of Ceftriaxone USP in an injectable vial.
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.