Salix Pharmaceuticals (SLXP) Confims FDA Panel Backing of XIFAXAN for Hepatic Encephalopathy
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Salix Pharmaceuticals, Ltd. (NASDAQ: SLXP) confirmed that the Gastrointestinal Drugs Advisory Committee of the FDA has recommended by a vote of 14 to 4 in favor of the approval of XIFAXAN Tablets, 550 mg for the maintenance of remission of hepatic encephalopathy (HE).
"We are very pleased with the advisory committee's support for the approval of XIFAXAN 550 mg tablets. If approved, XIFAXAN 550 mg will be the first new option for the management of hepatic encephalopathy in over 30 years," stated Bill Forbes, Pharm.D., Senior Vice President Research and Development and Chief Development Officer, Salix. "We believe the availability of XIFAXAN 550 mg has the potential to change the treatment paradigm for HE. Today's independent recommendation from the outside experts comprising the advisory committee reinforces the Company's confidence in the potential for XIFAXAN 550 mg to provide a solution for patients suffering from this serious condition."
"We are very pleased with the advisory committee's support for the approval of XIFAXAN 550 mg tablets. If approved, XIFAXAN 550 mg will be the first new option for the management of hepatic encephalopathy in over 30 years," stated Bill Forbes, Pharm.D., Senior Vice President Research and Development and Chief Development Officer, Salix. "We believe the availability of XIFAXAN 550 mg has the potential to change the treatment paradigm for HE. Today's independent recommendation from the outside experts comprising the advisory committee reinforces the Company's confidence in the potential for XIFAXAN 550 mg to provide a solution for patients suffering from this serious condition."
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