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Marketing exclusivity extended to January.

Product Management Today • Oct, 2006 • FDA Focus
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Salix Pharmaceuticals, Ltd., Raleigh, North Carolina, announced that the FDA granted Colazal (balsalazide) additional marketing exclusivity until January 8, 2007. The drug is an antiinflammatory agent approved for the treatment of mild-to-moderate ulcerative colitis. The additional exclusivity was based on the FDA's acceptance of the clinical package submitted by the company in June, in response to an FDA request for clinical information about the safe and effective use of Colazal in patients between five and 17 years of age with ulcerative colitis.


COPYRIGHT 2006 Medicom International, Inc. Reproduced with permission of the copyright holder. Further reproduction or distribution is prohibited without permission.
Copyright 2006, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.
NOTE: All illustrations and photos have been removed from this article.


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