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FDA Decision scheduled for Santarus (SNTS)

By Mike Brown on 11/23/2009 – 11:19 am PSTLeave a Comment

Santarus, Inc. (NASDAQ:SNTS) expects the FDA to decide by December 4, 2009 regarding its NDA for ZEGERID tablet product. A NDA (New Drug Application) for DM-1796 is also expected to be filed with the FDA the first quarter of 2010.

About Santarus

Santarus, Inc. is a specialty biopharmaceutical company focused on acquiring, developing and commercializing proprietary products that address the needs of patients treated by gastroenterologists and other physicians. The company’s current commercial efforts are focused on ZEGERID® (omeprazole/ sodium bicarbonate), which is indicated for the treatment of certain upper GI diseases and disorders, and on GLUMETZA® (metformin hydrochloride extended release tablets), which is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Santarus is also developing two late-stage lower GI product candidates, budesonide MMX® and rifamycin SV MMX®, for the U.S. market. Budesonide MMX is being investigated in two multicenter Phase III clinical trials for the induction of remission of mild or moderate active ulcerative colitis. Rifamycin SV MMX has been investigated in a Phase II clinical program in travelers’ diarrhea. More information about Santarus is available on the company’s Web site at

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