Salix granted pediatric exclusivity for Colazal anti-inflammatory

By Elaine Rigoli

Tampa, Fla., Aug. 28 - Salix Pharmaceuticals, Ltd. said Monday that the Food and Drug Administration has granted Colazal additional marketing exclusivity through Jan. 8.

The FDA accepted the clinical package the company submitted in June in response to a written request received from the FDA for clinical information about the safe and effective use of Colazal in pediatric patients between 5 and 17 years of age with ulcerative colitis.

Colazal (balsalazide disodium) capsules 750 mg 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.

Salix, based in Raleigh, N.C., develops prescription pharmaceutical products for the treatment of gastrointestinal diseases.

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