Date:12/14/2011

n connection with the information updating our label through the approved sNDA, or decides that such protected labeling can be omitted from the label of a generic product, we cannot predict the timeframe in which the FDA will make a decision regarding either ViroPharma's citizen petition for Vancocin or the approval of generic versions of Vancocin. If the FDA does not grant such three year exclusivity, or if exclusivity is granted and a generic manufacturer is nonetheless permitted to omit the protected data, and we are unable to change the FDA's bioequivalence recommendation for Vancocin, the threat of generic competition will be high. The entry of competing generic products will significantly affect our sales of Vancocin and our financial performance. These factors, and other factors, including, but not limited to those described in our annual report on Form 10-K for the year ended December 31, 2010 and quarterly reports on Form 10-Q filed with the Securities and Exchange Commission for the periods ended March 31, 2011, June 30, 2011 and September 30, 2011, could cause future results to differ materially from the expectations expressed in this press release. The forward-looking statements contained in this press release are made as of the date hereof and may become outdated over time. ViroPharma does not assume any responsibility for updating any forward-looking statements. These forward looking statements should not be relied upon as representing our assessments as of any date subsequent to the date of this press release.

 

 

'/>"/>

SOURCE ViroPharma Incorporated Copyright©2010 PR Newswire. All rights reserved

0 GOOD

Page: 1 2 3 4 5 6 7
Related medicine technology :

1. ViroPharma to Present at Three Upcoming Healthcare Conferences
2. ViroPharma to Present at the Natixis Bleichroeder Conference
3. ViroPharma To Present at the Acumen BioFin Rodman & Renshaw 9th Annual Healthcare Conference
4. ViroPharma to Release 2008 First Quarter Financial Results on April 30, 2008
5. ViroPharma Announces Discontinuation of HCV-796 Development
6. ViroPharma Announces Completion of Enrollment in Phase 3 Study of Maribavir in Stem Cell Transplant Patients
7. ViroPharma Incorporated Completes Acquisition of Lev Pharmaceuticals
8. ViroPharma Announces Presentation of Cinryze(TM) Data in Acute Treatment of Hereditary Angioedema
9. ViroPharma Announces Discontinuation of Maribavir Phase 3 Study in Liver Transplant Patients
10. ViroPharma Submits Comments on Vancocin(R) Draft Bioequivalence Guidance
11. ViroPharma Incorporated Reports Third Quarter 2009 Financial Results