Merck Announces FDA Acceptance of Application for Cordaptive

Merck reported that the new drug application (NDA) for Cordaptive, formerly known as MK-0524A, has been accepted for standard review by the FDA. 

Merck said it anticipates FDA action in the second quarter of 2008. The company is also moving forward with filings in other countries.

Data included in the application support the proposed use of Cordaptive, either alone or with a statin, as adjunctive therapy to diet for the treatment of elevated LDL cholesterol, low HDL cholesterol and elevated triglycerides levels, the company said. 

Cordaptive is an investigational compound containing Merck’s extended-release niacin and laropiprant, a novel inhibitor designed to reduce flushing often associated with niacin treatment, the company added.