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ViroPharma Announces Meeting of FDA Advisory Committee for Pharmaceutical Science and Clinical Pharmacology on Bioequivalence Recommendations for Oral Vancomycin Hydrochloride Products
Date:5/29/2009

EXTON, Pa., May 29 /PRNewswire-FirstCall/ -- The U.S. Food and Drug Administration (FDA) announced today that it will convene a meeting of its Advisory Committee for Pharmaceutical Science and Clinical Pharmacology to discuss bioequivalence recommendations for oral vancomycin hydrochloride capsule drug products. The meeting is scheduled for August 4, 2009. FDA will make background material available to the public no later than two days before the meeting at http://www.fda.gov/ohrms/dockets/ac/acmenu.htm.

Vancocin is the only approved product to treat Clostridium difficile-associated pseudomembranous colitis, one of the most common and devastating hospital-acquired infections. Clostridium difficile infection (CDI) can be severe, and without proper treatment, the associated complications of the disease can be deadly. The incidence of the disease observed in U.S. healthcare facilities more than doubled between 2000 and 2005; between 1999 and 2004, reported mortality rates from C. difficile in the U.S. more than quadrupled to 23.7 per million.

"ViroPharma views the convening of the advisory committee as a positive step towards open dialogue to discuss this very serious public health issue," commented Thomas Doyle, ViroPharma's vice-president, strategic initiatives. "ViroPharma will have an opportunity to address the Committee, and we look forward to what we hope will be a robust discussion of the many important issues raised by the Office of Generic Drugs' in vitro approach to bioequivalence for Vancocin."

About Clostridium difficile

One of the most serious problems facing the U.S. healthcare system today is hospital-acquired infections (HAIs). Clostridium difficile infection is one of the most co
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SOURCE ViroPharma Incorporated
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