EXTON, Pa., June 5 /PRNewswire-FirstCall/ -- ViroPharma Incorporated
(Nasdaq: VPHM) notes that FDA has published a notice of a meeting of its
Advisory Committee for Pharmaceutical Science and Clinical Pharmacology to
be held on July 23, 2008. The Committee will address several issues at this
meeting, including a discussion of:
" ... presentations from the Office of Generic Drugs (OGD) on the
bioequivalence methods for locally acting drugs that treat
gastrointestinal (GI) conditions ... "
For over two years, ViroPharma has called for a deliberative public discussion that would include input from clinicians as well as biopharmaceutics and dissolution experts. Bioequivalence determinations for locally acting GI drugs, particularly drugs like Vancocin(R) that treat a serious and potentially life threatening disease, are complex. Clostridium difficile infection results in significant morbidity and mortality, and has developed into a national health issue. The risk to patients of a product that is not bioequivalent to Vancocin in this setting is high.
"While the notice does not specifically identify Vancocin, ViroPharma intends to take every opportunity to ensure the points we've raised through our submissions will be brought forward to this committee," commented Thomas F. Doyle, ViroPharma's vice president, strategic initiatives.
ViroPharma is encouraged that FDA is taking this first step to allow a
critique of OGD's bioequivalence proposals. As the company noted in a
letter that it sent to FDA earlier this year (newly available on the
company's website at http://www.viropharma.com/OGDpetition/),
bioequivalence for Vancocin is deser
|SOURCE ViroPharma Incorporated|
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