Marketing exclusivity extended to
January.
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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.
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