Merck Receives Not Approvable Letter From FDA For MK-0524A (ER Niacin/laropiprant)
May 15th 2008Drug InformationCholesterol
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 further evaluate the benefit/risk profile of MK-0524A,” said Peter S. Kim, Ph. D.
More: continued here
No Comments »
Leave a Reply
You must be logged in to post a comment.
