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Executive Summary

Pharmacia plans to launch its second generation sulfasalazine product Dipentum (olsalazine) in early October following FDA approval on July 31. FDA approved Dipentum after a near three-year review at the agency. Pharmacia filed the NDA in late 1987. The drug received a "1-B" rating (new chemical entity representing a moderate therapeutic advance over existing treatments) from the FDA. According to the approved labeling, Dipentum is indicated for "the maintenance of remission of ulcerative colitis in patients who are intolerant of sulfasalazine." Pharmacia is pricing Dipentum 250 mg capsules to wholesalers at $38 per bottle of 100. Pharmacia's 25-person U.S. sales force already markets a 5-ASA drug for ulcerative colitis, Azulfidine (sulfasalazine), which has been available since 1941 for the treatment of inflammatory bowel diseases. An NDA for Azulfidine EN-tabs for the treatment of rheumatoid arthritis is pending at FDA ("The Pink Sheet" July 16, T&G-5-6). In granting approval for Dipentum, FDA did not give Pharmacia approval for use in treating acute ulcerative colitis -- an indication that Pharmacia was seeking in its initial NDA. In September 1988, FDA's Gastrointestinal Drugs Advisory Committee voted nine to one in support of recommending approval for Dipentum for maintaining remission of ulcerative colitis. The committee was less supportive of the acute indication, voting six-to-three with one abstention in recommending approval for use in treating acute ulcerative colitis ("The Pink Sheet" Sept. 19, 1988, T&G-1).



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