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ViroPharma Announces Support by Advisory Committee of The Office of Generic Drugs Proposed Guidelines for Developing Generic Versions of Oral Vancomycin Hydorchloride
Date:8/4/2009

generic products that:

(a) contain the same active and inactive ingredients in the same amounts as Vancocin( )HCl capsules;

(b) meet currently accepted standards for assay, potency, purity, and stability (equivalent to those in place for Vancocin( )HCl capsules); and

(c) are manufactured according to cGMP.

According to ViroPharma, the proposed in vitro test conditions do not mimic the in vivo environment of the CDI patient and the qualitative and quantitative sameness (Q1Q2) is inadequate given formulation and critical manufacturing process controls and lacks correlation with clinical effects. The company also underscored that the adoption of bioequivalence guidelines is precedent setting and patient safety must be a primary concern.

About Vancocin

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.

About Clostridium difficile Infection (CDI)

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. diff observed in U.S. healthcare facilities more than doubled between 2000 and 2005; between 1999 and 2004, reported mortality rates from C. diff in the U.S. more than quadrupled to 23.7 per million. Elderly patients exposed to antibiotics, long-
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SOURCE ViroPharma Incorporated
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Related medicine news :

1. ViroPharma Incorporated Reports Second Quarter 2009 Financial Results
2. ViroPharma to Release 2009 Second Quarter Financial Results on July 29, 2009
3. ViroPharma Announces Appointment of Frank Baldino, Jr., Ph.D. to Board of Directors
4. ViroPharma Announces Meeting of FDA Advisory Committee for Pharmaceutical Science and Clinical Pharmacology on Bioequivalence Recommendations for Oral Vancomycin Hydrochloride Products
5. ViroPharma to Present at Two May Healthcare Conferences
6. ViroPharma to Present at the Cowen & Company 29th Annual Healthcare Conference
7. ViroPharma to Host Investor Teach-In Educational Symposium on Hereditary Angioedema
8. ViroPharma to Release 2008 Fourth Quarter and Full Year Financial Results on February 24, 2009
9. ViroPharma Reports Results of Phase 3 Clinical Trial for Maribavir in Bone Marrow Transplant Patients
10. ViroPharma to Present at the 27th Annual J.P. Morgan Healthcare Conference
11. ViroPharma Provides Update on Vancocin(R)
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