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Merck & Co., Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended two medicines for marketing approval in the European Union (EU). The CHMP recommended marketing approval for TREDAPTIVE™ (nicotinic acid/ laropiprant, MSD) 1000 mg/20 mg tablets for patients with dyslipidemia or primary hypercholesterolemia. Separately, the U.S. Food and Drug Administration (FDA) is currently reviewing the combination of extended release (ER) niacin and laropiprant under the trademark CORDAPTIVE™ (ER niacin/laropiprant). The CHMP recommendation does not apply to regulatory decisions by the FDA and no inferences should be made about pending FDA regulatory actions based on the recommendation of the CHMP.
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