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Santarus Inc. (SNTS) Announces FDA Extension of UCERIS New Drug Application Target Action Date to January 16, 2013


8/14/2012 9:25:36 AM

SAN DIEGO--(BUSINESS WIRE)--Santarus, Inc. (NASDAQ: SNTS) today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) target action date for the review of the New Drug Application (NDA) for UCERIS™ (budesonide) tablets 9 mg for the induction of remission of mild to moderate active ulcerative colitis from October 16, 2012 to January 16, 2013. The three-month extension is a standard extension period.

Read at BioSpace.com


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