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news.In a bid to extend its period of market exclusivity, Salix Pharmaceuticals has submitted more information to the FDA to demonstrate that its Colazal drug is safe and effective in pediatric patients with ulcerative colitis aged five to 17.
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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.