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.
This entry was posted
on Wednesday, April 30th, 2008 at 8:00 am and is filed under Cholesterol.
You can follow any responses to this entry through the RSS 2.0 feed.
You can leave a response, or trackback from your own site.
