ViroPharma told Vanocin not focus of OGD meeting by FDA

13 July 2008

Pennsylvania, USA-based ViroPharma has been informed by the US Food and Drug Administration that the July 23 meeting of its Advisory Committee for Pharmaceutical Science and Clinical Pharmacology is not intended to discuss specifically ViroPharma's Vancocin (vancomycin hydrochloride capsules) or any other drug products.

The FDA has informed the US firm that the Office of Generic Drugs will only present for the Committee's consideration issues of general applicability to all locally-acting drugs that treat gastrointestinal conditions. Any resulting recommendations by the Committee will be similarly general in nature, said the Agency. ViroPharma has been advised that it will be afforded no more time to speak at the meeting than any other member of the public, consistent with the non-product specific focus of the meeting, and the company notes that the time to be provided to any one speaker will be very limited. Based on the FDA's statements, ViroPharma says it will not discuss Vancocin at the meeting.

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