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www.fdanews.com/articles/75871-baxter-receives-fda-approval-for-ceftriaxone-injection

BAXTER RECEIVES FDA APPROVAL FOR CEFTRIAXONE INJECTION

August 29, 2005

Baxter Healthcare has received approval from the FDA for Ceftriaxone injection, USP 1g/50 mL and 2g/50 mL, packaged in single-dose plastic containers. Baxter 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 in mid-September.

Baxter's 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.