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ViroPharma Submits Comments on Vancocin(R) Draft Bioequivalence Guidance
Date:3/18/2009

ctions present new hurdles to the approvability of existing oral vancomycin ANDAs. For example, FDA's own data demonstrate that Vancocin is not rapidly dissolving, which was a key element of the earlier OGD recommendation. All products for which ANDAs were filed prior to December 2008 presumably purported to satisfy the now discarded "rapid dissolution" BE standard. Unless those products are reformulated, ViroPharma believes they should not possess "comparable dissolution" profiles to Vancocin as required by the December 2008 draft Vancocin BE method. In addition, there is one inactive ingredient that ViroPharma believes contributes to important performance characteristics of the product that is maintained by ViroPharma as a trade secret. If this inactive ingredient is not present in generic versions of Vancocin, ViroPharma believes those products would fail OGD's proposed Q1Q2 standard.

ViroPharma's comments to the December 2008 draft bioequivalence guidance can be found on FDA's website at http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=FDA-2008-D-0626, or on ViroPharma's website at http://www.viropharma.com/about%20us/ogd%20petition.aspx.

About Vancocin(R)

Vancocin(R) HCL Capsules is 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. Orally administered Vancocin Capsules are not effective for other types of infection.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancocin Capsules and other antibacterial drugs, Vancocin Capsules shou
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SOURCE ViroPharma Incorporated
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