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Salix balsalazide

Executive Summary

Second "approvable" letter for the ulcerative colitis therapy issued March 24 indicates that approval of the drug will await the determination of what comparative claims will be allowed in labeling between balsalazide and Procter & Gamble's Asacol (mesalamine), Salix said. FDA also rescinded its approval of the brand name BalAsa March 24, citing potential name confusion with Roberts' Pentasa. Salix plans to respond in April with a submission that will include a new brand name, a formal response to the proposed label, and updated safety data from recently completed balsalazide clinical trials. The agency first deemed the drug approvable June 15, 1998
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PS035827

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