PHARMACIA WILL LAUNCH DIPENTUM (OLSALAZINE) IN EARLY OCTOBER
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).
You may also be interested in...
Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Shire Hopes To Sow Future Deals With $50M Venture Fund
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth