The company is attempting to take advantage of an FDA scheme that extends a product’s period of exclusivity if a company conducts tests to prove the safety and efficacy of the product in children.
Assuming the clinical package is accepted as a complete response to the FDA’s pediatric data request, Colazal will be granted additional marketing exclusivity until January 8, 2007.
Colazal Capsules 750mg is an anti-inflammatory drug approved for the treatment of mildly to moderately active ulcerative colitis. Safety and effectiveness of the drug beyond 12 weeks has not been established.