Salix Pharmaceuticals Ltd. (SLXP) announced that the U.S. Food and Drug Administration has granted Priority Review designation for the Company's New Drug Application or 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 or AIDS on anti-retroviral therapy or ART.
The company noted that FDA has issued an action date for the NDA of June 5, 2012 under the Prescription Drug User Fee Act (PDUFA).
"This review classification signals that the FDA believes that crofelemer has the potential to provide a significant advance in the treatment of HIV/AIDS-associated diarrhea for patients on ART. We believe the availability of crofelemer has the potential to change the treatment paradigm for HIV/AIDS patients suffering from diarrhea," said Bill Forbes, Executive Vice President, Medical, Research and Development, and Chief Development Officer, Salix.
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