Santarus Inc. Announces FDA Acceptance of UCERIS New Drug Application for Induction of Remission of Active Ulcerative Colitis
Published: Feb 15, 2012
SAN DIEGO--(BUSINESS WIRE)--Santarus, Inc. (NASDAQ: SNTS) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the company’s New Drug Application (NDA) for UCERIS™ (budesonide) tablets 9 mg. Pursuant to Prescription Drug User Fee Act (PDUFA) guidelines, Santarus expects the FDA will complete its review or otherwise respond to the UCERIS NDA by mid-October, 2012. Santarus is seeking marketing approval in the U.S. of UCERIS 9 mg for the induction of remission of mild to moderate active ulcerative colitis.