Colazal Food Effect Application Granted FDA Approval
RALEIGH, N.C., September 27, 2006 -- Salix Pharmaceuticals, Ltd. announces that the U.S. Food and Drug Administration approved a supplemental new drug application which provides for changes to the approved labeling for Colazal based upon the pharmacokinetics of Colazal administered with food as well as sprinkled over food.
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. Colazal was well tolerated in clinical studies. In clinical trials, patients reported the following adverse events most frequently: headache (8%); abdominal pain (6%); diarrhea (5%); nausea (5%); vomiting (4%); respiratory infection (4%); and arthralgia (4%). Withdrawal from therapy due to adverse events was comparable to placebo.
Source: Salix Pharmaceuticals, Ltd.
Posted: September 2006
