Salix Pharmaceuticals (SLXP) Submits NDA to FDA for Balsalazide Tablet
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Salix Pharmaceuticals, Ltd. (NASDAQ: SLXP) has submitted to the U.S. Food and Drug Administration (FDA) a New Drug Application (NDA) seeking approval to market a 1100 milligram tablet formulation of balsalazide disodium (balsalazide tablet). Balsalazide disodium is the active ingredient in COLAZAL Capsules 750 mg, the Company's anti-inflammatory drug approved and marketed for the treatment of mildly to moderately active ulcerative colitis. Salix believes this application is subject to a 10-month review period.
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