Home » Santarus Announces FDA Extension of UCERIS PDUFA Action Date to Jan. 16
Santarus Announces FDA Extension of UCERIS PDUFA Action Date to Jan. 16
Santarus said that the FDA has extended the Prescription Drug User Fee Act (PDUFA) target action date for the review of the NDA for UCERIS (budesonide) tablets 9 mg for the induction of remission for mild to moderate active ulcerative colitis from Oct. 16, 2012, to Jan. 16, 2013.
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