Santarus Submits NDA for UCERIS Tablets
UCERIS is being developed in collaboration with Cosmo Technologies. Upon acceptance for review of the NDA for UCERIS Tablets, $4 million is payable to Cosmo.
California-based specialty biopharmaceutical company Santarus, Inc. announced Tuesday that it has submitted a New Drug Application (NDA) to the U.S. FDA seeking market approval for UCERIS (budesonide) Tablets 9 mg for the induction of remission of mild to moderate active ulcerative colitis.
UCERIS is being developed in collaboration with Cosmo Technologies Limited, a subsidiary of Cosmo Pharmaceuticals S.p.A. Upon acceptance for review of the NDA for UCERIS Tablets, $4 million is payable to Cosmo Technologies Limited. The milestone is payable in cash or Santarus common stock, at Cosmo's option.
UCERIS was evaluated for the treatment of patients with mild or moderate active ulcerative colitis in two Phase III pivotal clinica
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