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FDA Office Of Drug Evaluation III Approves Salix Pharmaceuticals, Ltd. (SLXP)’s Request That The FDA Approve The RELISTOR® Subcutaneous Injection sNDA For The Treatment Of Opioid-Induced Constipation In Patients With Chronic Non-Cancer Pain



7/14/2014 11:32:00 AM

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RALEIGH, N.C. & TARRYTOWN, N.Y.--(BUSINESS WIRE)--Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) and Progenics Pharmaceuticals (NASDAQ:PGNX) today announced that the Food and Drug Administration (FDA or Agency) has informed Salix that RELISTOR® (methylnaltrexone bromide) Subcutaneous Injection, 20 mg/ml, for the treatment of opioid-induced constipation (OIC) in patients taking opioids for chronic non-cancer pain can be approved on the data submitted in the sNDA. The FDA Office of Drug Evaluation III responded to the Company’s formal appeal filed in response to the Complete Response Letter (CRL) of July 27, 2012 to the supplemental NDA (sNDA) for RELISTOR. The Agency’s letter stated that, “Salix’s request that FDA approve the supplemental NDA for RELISTOR subcutaneous injection for the treatment of opioid-induced constipation in patients with chronic non-cancer pain based on the submitted data is granted.”

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