Merck’s Cholesterol Drug “Not Approvable”

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Merck received a Not Approvable action letter from the FDA regarding its 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 further evaluate the benefit/risk profile of MK-0524A,” said Peter S. Kim, Ph. D. executive vice president and president, Merck Research Laboratories.     “We firmly believe that MK-0524A provid...

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