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.
On August 3, 2012, following the FDA's request, Santarus submitted
additional information for the Office of Scientific Investigations,
which is the division of the FDA responsible for ensuring compliance
with Good Clinical Practices (GCP), in connection with U.S. and ex-U.S.
pre-approval inspections. On August 10, 2012, the company received a
communication from the FDA that the submission has been classified as a
major amendment to the NDA. Since the submission was received within
three months of the target action date, the FDA is extending the PDUFA
date by three months to provide time for a full review of the submitted
information.