Flushing

Merck Announces FDA Acceptance of NDA for CORDAPTIVE (ER niacin/laropiprant), Formerly Known as MK-0524A, an Investigational Lipid-Modifier

Published in Medical Letter on the CDC and FDA, September 16th, 2007

Merck & Co., Inc. announced that the New Drug Application (NDA) for CORDAPTIVE(TM) (ER niacin/laropiprant), formerly known as MK-0524A, has been accepted for standard review by the U.S. Food and Drug Administration (FDA). Merck anticipates FDA action in the second quarter of 2008. The Company is also moving forward as planned with filings in countries outside the United States.

CORDAPTIVE is an investigational compound containing Merck's own extended-release niacin and laropiprant, a novel flushing pathway inhibitor designed to reduce flushing often associated with niacin treatment. Data included in the application support the proposed use of CORDAPTIVE, either alone or...

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Source: Medical Letter on the CDC and FDA (2007-09-16)

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