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Baxter gets US FDA green signal for Fluconazole

DeerfieldWednesday, August 11, 2004, 08:00 Hrs  [IST]

Baxter Healthcare Corporation has received approval from the US FDA for intravenous anti-fungal, Fluconazole Injection. The product is a generic version of injectable Diflucan (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 per cent injection and 400mg/200mL in Sodium Chloride 0.9 per cent injection. "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 US. 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.

 
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