Only Frozen, Premixed Presentation Offers Clinicians Ease of Use and Supports Medication Error Reduction

 

DEERFIELD, Ill., August 29, 2005 – Baxter Healthcare Corporation announced today that it has received approval from the U.S. Food and Drug Administration (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.

 

“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 U.S. 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.”

 

Baxter’s proprietary Galaxy® manufacturing process incorporates the admixture and 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.

 

About Ceftriaxone

 

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. Ceftriaxone is contraindicated in patients with a known allergy to the cephalosporin class of antibiotics. It should be given cautiously to penicillin-sensitive patients. Mild to life threatening pseudomembranous colitis has been reported in nearly all antimicrobial agents, including ceftriaxone. Ceftriaxone is generally well tolerated. Adverse events may include local reactions, hypersensitivity, diarrhea, rash, elevation of liver function tests, eosinophilia, thrombocytosis and leucopenia. For more information, including full prescribing information, visit www.baxter.com.

 

About Baxter

 

Baxter Healthcare Corporation is the principal U.S. operating subsidiary of Baxter International Inc. (NYSE: BAX). Baxter International Inc., through its subsidiaries, assists healthcare professionals and their patients with treatment of complex medical conditions, including cancer, hemophilia, immune disorders, kidney disease and trauma. The company applies its expertise in medical devices, pharmaceuticals and biotechnology to make a meaningful difference in patients' lives. For more information about Baxter, please visit www.baxter.com.

 

Rocephin® is a registered trademark of Roche Pharmaceuticals

 

This release includes forward-looking statements concerning the availability of Ceftriaxone. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: completion of final steps in product development, including scaling up production, including satisfactory quality and regulatory work; and other risks identified in the company’s most recent filing on Form 10-Q and other SEC filings, all of which are available on the company’s web site. The company does not undertake to update its forward-looking statements.