Deerfield, Ill., August 3, 2004 – Baxter Healthcare Corporation announced today that it has received approval from the U.S. Food and Drug Administration (FDA) for a generic formulation of the commonly used, intravenous anti-fungal, Fluconazole Injection.  The product is a generic version of injectable Diflucan® (marketed by Pfizer Inc.), an agent used in the treatment of serious fungal ( Candida ) infections. 

Baxter's Fluconazole is available in a premix, ready-to-use flexible container as 200mg/100mL in Sodium Chloride 0.9% injection and 400mg/200mL in Sodium Chloride 0.9% injection.

In line with Baxter's commitment to a safer healthcare environment, Baxter's product will feature the ENLIGHTENED HRBC  Bar Code – a next-generation, high-resolution bar code technology for flexible IV bags that includes lot number and expiration date, information that may be helpful in assuring correct dosing, easier tracking and administration.  Additionally, the distinctive labeling and packaging is designed to enhance product differentiation.

“Fluconazole is another addition to Baxter's extensive line of premixed medications in flexible containers for immediate use.  This generic formulation is another example of how we leverage our manufacturing expertise to continue to provide therapies in delivery systems that are designed with features to reduce the opportunity for medication error,” said David Bonderud, president of Baxter's Medication Delivery business in the U.S. 

Fluconazole is indicated in the treatment of oropharyngeal and esophageal candidiasis, Candida urinary tract infections, peritonitis, systemic Candida infections including candidemia, disseminated candidiasis and pneumonia. It is also indicated for the treatment of cryptococcal meningitis and to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy.  There have been rare cases of serious hepatic reactions during treatment with fluconazole. Fatal reactions were noted to occur primarily in patients with serious underlying medical conditions (i.e., AIDS or malignancy) and often while taking multiple concomitant medications. Fluconazole is contraindicated in patients who have shown hypersensitivity to fluconazole or any of its excipients.  For full prescribing information, please view the  package insert, or call Baxter's Product Information Center at 1-800 933-0303.

Baxter Healthcare Corporation is the principal U.S. operating subsidiary of Baxter International Inc. (NYSE: BAX). Baxter 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 .

Baxter and Enlightened HRBC are trademarks of Baxter International Inc.
Diflucan is a registered trademark of Pfizer Inc.