EXTON, Pa., July 8 /PRNewswire-FirstCall/ -- ViroPharma Incorporated (Nasdaq: VPHM) has been informed by U.S. Food and Drug Administration (FDA) that the July 23, 2008 meeting of its Advisory Committee for Pharmaceutical Science and Clinical Pharmacology is not intended to discuss specifically ViroPharma's Vancocin(R) (vancomycin hydrochloride capsules) or any other drug products. Rather, FDA has informed ViroPharma that FDA's Office of Generic Drugs (OGD) will only present for the Committee's consideration issues of general applicability to all locally acting drugs that treat gastrointestinal (GI) conditions. FDA also informed ViroPharma that any resulting recommendations by the Committee will be similarly general in nature. Additionally, ViroPharma has been advised that it will be afforded no more time to speak at the meeting than is afforded to any other member of the public, consistent with the non-product specific focus of the meeting. ViroPharma understands that the time to be provided to any one speaker will be very limited.
Based on FDA's statements to ViroPharma regarding the purpose of this
meeting, made by both Committee staff and FDA's Office of Chief Counsel,
ViroPharma will not discuss Vancocin at this meeting. Given ViroPharma's
experience in this area, and the limited time available to speakers at the
meeting, ViroPharma today submitted a letter to the Committee to aid its
consideration of the general issue of bioequivalence methods for locally
acting GI drugs. Among other things, ViroPharma's letter notes important
issues that must be addressed in this complex area of bioequivalence method
development, and attaches for the Committee's review a letter sent to FDA
last year by the Infectious Diseases Society of Ameri
|SOURCE ViroPharma Incorporated|
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