FDA Advisory committee rejects lixivaptan - 15-Sep-2012
The Cardiovascular and Renal Drugs Advisory Committee of the FDA has recommended againstthe approval of lixivaptan from CardioKine/Cornerstone for the treatment of symptomatic hypervolemic and euvolemic Hyponatraemia associated with Heart Failure. The panel also voted 5-3 against the drug's use in Syndrome of Inappropriate Antidiuretic Hormone (SIADH).The risks of the drug outweighed its modest benefit in raising sodium levels and suggested more trials are required.The FDA has assigned a Prescription Drug User Fee Act goal date of October 29, 2012.
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