Salix Pharmaceuticals Announces Extension of Crofelemer NDA Priority Review
Salix Pharmaceuticals, Ltd. (NASDAQ: SLXP) today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for the Agency's Priority Review of the 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 has notified Salix that it requires additional time for a full review of the submission and has extended the June 5, 2012 goal date by three months. The extended user fee goal date is September 5, 2012. The FDA did not request additional studies.
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