Cadence Pharmaceuticals, Inc. (NASDAQ: CADX) today confirmed that the U.S. Food and Drug Administration (FDA) approved dosing recommendations for OFIRMEV® (acetaminophen) injection remains 4,000 mg per day for adults and adolescents weighing at least 50 kg.
Cadence's announcement follows the issuance of a news release by a major manufacturer of over-the-counter (OTC) acetaminophen products announcing its plans to lower the recommended maximum daily dose of some oral acetaminophen products in an effort to reduce the risk of accidental acetaminophen overdose among consumers in the OTC setting.
"We believe it is important that healthcare providers know that the new recommended dosing guidelines for the OTC products do not affect the recommended dosing guidelines for OFIRMEV," said James Breitmeyer, M.D., Ph.D., Chief Medical Officer of Cadence Pharmaceuticals. "The safety and effectiveness of OFIRMEV at 4,000 mg per day has been well established in numerous clinical trials and is supported by extensive experience with the drug in Europe, where it has been the foundation of IV pain management since its introduction in 2002. Healthcare professionals should continue to administer OFIRMEV as recommended in the FDA-approved package insert."
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