The company received the extended exclusivity after the FDA accepted for review a clinical package submitted by the company which contained data about the use of Colazal in pediatric patients between 5 and 17 years of age with ulcerative colitis. The company submitted the pediatric data on June 20, 2006 in response to a written request from the FDA.
Extended exclusivity is sometimes granted to pharmaceutical products if they can be shown to be safe and effective in the pediatric population.
Colazal capsules 750mg, is an anti-inflammatory drug approved for the treatment of mildly to moderately active ulcerative colitis. Safety and effectiveness of Colazal beyond 12 weeks has not been established.