|
|
Article: ViroPharma Files FOIA Complaint Seeking Administrative Record for Vancocin(R).
- Article from:
- PR Newswire
- Article date:
- December 18, 2008
CopyrightCOPYRIGHT 2008 PR Newswire Association LLC. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
|
EXTON, Pa., Dec. 18 /PRNewswire-FirstCall/ -- ViroPharma Incorporated 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 ...