Salix Pharmaceuticals' (SLXP) NDA for Crofelemer 125mg Tablets Receive Priority Review by FDA
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Salix Pharmaceuticals, Ltd. (NASDAQ: SLXP) today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review designation for the Company’s New Drug Application (NDA) for crofelemer 125 mg tablets for the proposed indication for the control and symptomatic relief of diarrhea in patients with human immunodeficiency virus (HIV)/acquired immune deficiency syndrome (AIDS) on anti-retroviral therapy (ART).
The FDA grants a Priority Review designation to drugs offering major advances in treatment, or providing a treatment where no adequate therapy exists. Based on this review classification, the FDA has issued an action date for the NDA of June 5, 2012 under the Prescription Drug User Fee Act (PDUFA).
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The FDA grants a Priority Review designation to drugs offering major advances in treatment, or providing a treatment where no adequate therapy exists. Based on this review classification, the FDA has issued an action date for the NDA of June 5, 2012 under the Prescription Drug User Fee Act (PDUFA).
Get immediate access to market moving news and alerts with StreetInsider.com Premium - FREE TRIAL!
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