MARIETTA, GA–A U.S. Food and Drug Administration advisory panel voted to reject an experimental drug to treat irregular heartbeats from Solvay Pharmaceuticals.
The panel’s decision is not binding on the FDA. It requested more information about the drug tedisamil and the company says it will cooperate.
The company filed its innovative new drug application a year ago and expects the FDA to make a decision by January. A rejection by the advisory panel could affect its decision.
ON the the Web: www.solvay.com
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