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ViroPharma Submits Comments on Vancocin(R) Draft Bioequivalence Guidance
Date:3/18/2009

ld be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. Adverse events include nephrotoxicity, ototoxicity, reversible neutropenia and "Red Man's Syndrome." Infrequently, allergic reactions have been reported. Clinically significant serum concentrations have been reported in some patients treated with Vancocin Capsules for pseudomembranous colitis caused by C. difficile. It is noteworthy that total systemic and renal clearance of vancomycin are reduced in the elderly. Monitoring of serum concentrations may be appropriate in patients with renal insufficiency and/or colitis.

About C. difficile Infection

C. difficile is a bacterium, which under certain circumstances, typically after antibiotic therapy, can colonize the lower gastrointestinal tract where it may produce toxins which cause inflammation of the colon and diarrhea. Without proper treatment, the associated complications of the disease can be deadly. Advanced age, gastrointestinal surgery/manipulation, long length of stay in healthcare settings, a serious underlying illness and compromised immunity are conditions associated with increased risk of disease. According to the U.S. Centers for Disease Control and Prevention (CDC), there are an estimated 400,000 to 500,000 community- and healthcare-associated CDAD cases annually based on 2004 data.

About ViroPharma Incorporated

ViroPharma Incorporated is a biopharmaceutical company dedicated to the development and commercialization of products that address serious diseases treated by physician specialists and in hospital settings. ViroPharma commercializes Vancocin(R) (vancomycin hydrochloride capsules, USP), approved for oral administration for treatment of antibiotic-associated pseudomembranous colitis caused by Clostridium difficile and enterocolitis caused by Staphyl
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