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MK-0524A FDA 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 timeline for MK-0524A

Jun 20, 2008Merck Provides Update on U.S. Regulatory Status of MK-0524A (ER niacin/laropiprant) and MK-0524B (ER niacin/laropiprant/simvastatin)
Apr 29, 2008Merck Receives Not Approvable Letter from FDA for MK-0524A (ER niacin/laropiprant)
Aug 29, 2007Merck Announces FDA Acceptance of NDA for Cordaptive (ER niacin/laropiprant), Formerly Known as MK-0524A, an Investigational Lipid-Modifier

Further information

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