Published in Drug Law Weekly, November 6th, 2007
Based on Biovail's discussions with the FDA in an August 14, 2007 meeting, and in accordance with FDA feedback, the submission includes new analyses of the data included in the original New Drug Application (NDA) for BVF-033, but does not include results from any new studies. Biovail anticipates receiving a response from the FDA in the near term. The Company believes the data package is...
Want to see the full article?
Welcome to NewsRx!
Learn more about a six-week, no-risk free trial of Drug Law Weekly