Article: ViroPharma Submits Comments on Vancocin(R) Draft Bioequivalence Guidance.

Article: ViroPharma Provides Update on Vancocin(R).
PR Newswire;  December 15, 2008 ;     700+ words ... ... Administration (FDA) has posted draft guidance for establishing bioequivalence (BE) to Vancocin. The new draft guidance is open for public comment ... BE recommendation for Vancocin. Nowhere in the draft guidance does it indicate that ...

Article: ViroPharma Provides Update on Vancocin(R)
U.S. Newswire;  December 15, 2008 ;     700+ words ... ... Administration (FDA) has posted draft guidance for establishing bioequivalence (BE) to Vancocin. The new draft guidance is open for public comment ... BE recommendation for Vancocin. Nowhere in the draft guidance does it indicate that ...

Article: ViroPharma Provides Update on Vancocin.
Biotech Week;  December 31, 2008 ;     596 words ... ... provided the following update regarding Vancocin(R) (vancomycin hydrochloride ... Administration (FDA) has posted draft guidance for establishing bioequivalence (BE) to Vancocin. The new draft guidance is open for public comment, and ...

Article: ViroPharma Loses Vancocin Try; FDA Panel Vote Favors ...
BIOWORLD Today;  August 5, 2009 ;     700+ words ... ... trial data were submitted. Vancocin's application for the oral ... drugmakers seeking to use Vancocin as a reference product. But ... the meeting. The FDA issued draft guidance in December 2008, which has ... approving a generic version of Vancocin. ViroPharma has argued that ...

Article: ViroPharma Files FOIA Complaint Seeking Administrative Record for ...
Biotech Week;  December 31, 2008 ;     700+ words ... ... required manufacturers of generic copies of Vancocin to show that the generic is bioequivalent to Vancocin through in vivo testing (see also Biotechnology ... administrative record relating to FDA's Vancocin bioequivalence guidance of December 15 ...

Article: VIROPHARMA BUYING VANCOCIN RIGHTS FROM LILLY FOR ...
BIOWORLD Today;  October 20, 2004 ;     700+ words ... ... Lilly and Co. all U.S. rights to Vancocin products for $116 million, slightly ... 40 million of the product known as Vancocin Pulvules last year, but in 2004, sales ... offered Lilly more than $116 million. Vancocin (vancomycin hydrochloride) is the only ...

Article: ViroPharma Incorporated Reports First Quarter 2006 Financial ...
PR Newswire;  May 4, 2006 ;     700+ words ... ... Underlying prescription demand for Vancocin, measured by IMS, grew 39 percent over ... party manufacturing and supply chain for Vancocin approved; and -- Petition filed with FDA to stay approval of generic versions of Vancocin in the absence of appropriate standards ...