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Merck Receives Not Approvable Letter From FDA For MK-0524A (ER Niacin/laropiprant)

by herbal review @ 1:57 pm on May 14, 2008.

Merck & Co., Inc. received a Not Approvable action letter from the U.S. Food and Drug Administration (FDA) for the Company’s New Drug Application (NDA) for MK-0524A (ER niacin/laropiprant) for the treatment of primary hypercholesterolemia or mixed dyslipidemia.
“We plan to meet with the FDA and to submit additional information to enable the agency to […]

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