FDA extends PDUFA target action date for review of Santarus' UCERIS NDA

Aug 14 2012

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.

The FDA also indicated that if major deficiencies are not identified during the review of the NDA, the FDA plans to communicate proposed labeling and, if necessary, any postmarketing requirement/commitment requests to Santarus by December 12, 2012. Assuming FDA approval, Santarus anticipates that it will be in a position to commence the launch of UCERIS approximately two months following the determination of the final product label.

UCERIS is an investigational drug that is a locally acting, non-systemic corticosteroid in a novel, patented, oral tablet formulation that utilizes proprietary MMX^® multi-matrix system technology, which is designed to result in the controlled release and distribution of budesonide throughout the length of the colon. Budesonide has topical anti-inflammatory activity and due to an extended first pass effect, has less systemic absorption than other corticosteroids. UCERIS is being developed in collaboration with Cosmo Technologies Limited, a subsidiary of Cosmo Pharmaceuticals S.p.A.