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FDA ACCEPTS SALIX NDA FOR PRIORITY REVIEW.

Publication: Biotech Business
Publication Date: 01-OCT-09 		Format: Online
Delivery: Immediate Online Access

Article Excerpt
Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) has announced the Food and Drug Administration (FDA) has accepted for filing and designated for Priority Review the Company's New Drug Application (NDA) for rifaximin tablets 550 mg for the maintenance of remission of hepatic encephalopathy (HE). Additionally, the FDA has informed the Company of its plan to schedule an Advisory Committee meeting in late February 2010 to discuss the application.

A Priority Review classification is granted to drugs offering major advances in treatment, or providing a treatment where no adequate therapy exists. Based on this classification, the FDA has issued an action date of December 24, 2009 under the Prescription Drug User Fee Act (PDUFA). However, the convening of an Advisory Committee in late February 2010 signals the December 24, 2009 action date will be delayed.

"We are pleased with the FDA's acceptance for...

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