Published in Medical Letter on the CDC and FDA, October 1st, 2006
The exclusivity is based upon the FDA's acceptance of the clinical package the company submitted on June 20, 2006 in response to a written request received from the U.S. Food and Drug Administration for clinical information about the safe and effective use of Colazal in pediatric patients between 5 and 17 years of age with ulcerative colitis.
The FDA has informed Salix that the new marketing exclusivity expiration date for Colazal will be posted in the Electronic Orange Book (EOB) at the...
Want to see the full article?
Welcome to NewsRx!
Learn more about a six-week, no-risk free trial of Medical Letter on the CDC and FDA