Salix Pharmaceuticals, Ltd. (SLXP) said it expects to receive a Complete Response Letter on or before the March 7, 2011 PDUFA goal date for the supplemental New Drug Application, also called sNDA, for XIFAXAN 550 mg tablets.
XIFAXAN is for the proposed indication of treatment of non-constipation irritable bowel syndrome and IBS-related bloating.
Until the company is in receipt of the Complete Response Letter, it has limited information as to its complete content.
Based on a telephone conversation, the company is of the understanding that the FDA deems the XIFAXAN 550 mg sNDA is not ready for approval primarily due to a newly expressed need for retreatment information.
The company will therefore consider next steps with respect to the XIFAXAN 550 mg sNDA for non-C-IBS following receipt of a Complete Response Letter.
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