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ViroPharma Provides Update on Upcoming FDA Advisory Committee Meeting to Discuss Bioequivalence of Locally Acting Gastrointestinal Drugs
Date:7/8/2008

that FDA has previously afforded locally acting GI drugs such as cholestyramine, mesalamine, and sucralfate that are used to treat far less serious diseases where the consequence associated with getting it wrong do not pose as great a risk to patients.

ViroPharma's filings detailing these requirements are available on ViroPharma's website at http://www.viropharma.com/OGDpetition/.

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 common and devastating HAIs. The incidence of C. difficile 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. Elderly patients exposed to antibiotics, long-term care patients, or those that have a serious underlying illness, are at greatest risk to contract the disease. Patients with this disease have GI tract conditions that are significantly different from those of a healthy individual due to infection. Typical symptoms include diarrhea, fever, nausea and abdominal pain and dehydration, though cases can lead to life threatening complications such as megacolon, peritonitis and perforation of the colon.

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), approved for oral administration for treatment of antibiotic-associated pseudomembranous colitis caused by Clostridium difficile and enterocolitis caused by Staphylococcus aureus, including methicillin-resistant strains (for prescribing information, please download the package insert
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SOURCE ViroPharma Incorporated
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