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Biotechnology Business
ViroPharma Files FOIA Complaint Seeking Administrative Record for Vancocin(R)
January 3rd, 2009
ViroPharma Incorporated (NASDAQ:VPHM) filed suit against the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) in Federal District Court for the District of Columbia under the Freedom of Information Act (FOIA). In its FOIA action, ViroPharma seeks the administrative record relating to FDA's decision in March 2006 to change its long-standing interpretation of its regulations that required manufacturers of generic copies of Vancocin to show that the generic is bioequivalent to Vancocin through in vivo testing. ViroPharma made its first request for the administrative record to FDA in March 2006. FDA acknowledged its receipt of...
Source: Law & Health Weekly (2009-01-03)
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