Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

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).
UsernamePublicRestriction

Register

PS018036

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel