MK-0524A Approval Status

• FDA approved: No
• Brand name: MK-0524A
• Generic name: niacin ER and laropiprant
• Previous name: Cordaptive
• Company: Merck & Co., Inc.
• Treatment for: Hyperlipoproteinemia Type IIa, Elevated LDL, Hypertriglyceridemia

MK-0524A is an investigational compound containing extended-release niacin and laropiprant, a novel flushing pathway inhibitor designed to reduce flushing often associated with niacin treatment. MK-0524A is intended for use either alone or with a statin, as adjunctive therapy to diet for the treatment of elevated LDL cholesterol, low HDL cholesterol and elevated triglyceride levels.

In April 2008, Merck announced the receipt of a Not Approvable Letter from the U.S. Food and Drug Administration (FDA) advising the company that the New Drug Application (NDA) for MK-0524A had not been approved.

Development Status and FDA Approval Process for MK-0524A

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.