-- August 2007 Docket submission by ViroPharma providing comments on the
FDA's Draft Guidance for Industry on Bioequivalence Recommendations for
Specific Products; and
-- May 2007 Docket submission by ViroPharma discussing the bioequivalence
issue in more detail and clarifying the types of testing ViroPharma
believes are required to demonstrate bioequivalence and to provide an
adequate basis for determining whether a BCS-based biowaiver to
establish bioequivalence for Vancocin results in an acceptable level of
risk to patients and public health.
ViroPharma remains committed to assuring the safety of patients suffering from C. difficile infection and continues to oppose vigorously any bioequivalence approach considered for use in approving generic formulations of Vancocin that does not require rigorous scientific methods developed through public process to demonstrate bioequivalence. The company is committed to ensuring safety and efficacy of the drug consistent with good medicine, science, and the law.
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 CA-CDAD and HA-CDAD cases annually based on 2004 data.
About the OPS
The OPS, an office within the FDA's Center for Drug Evaluation and
Research (CDER), oversees the activities of chemistry, manufacturing and
|SOURCE ViroPharma Incorporated|
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