Merck & Co., Inc. (MRK) Announces FDA Acceptance of New Drug Application for Suvorexant, an Investigational Insomnia Medicine
11/8/2012 10:35:16 AM
WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the New Drug Application (NDA) for suvorexant, the company's investigational insomnia medicine, has been accepted for standard review by the U.S. Food and Drug Administration (FDA). Suvorexant will be evaluated by the Controlled Substance Staff of the FDA during NDA review. If approved by the FDA, suvorexant will become available after a schedule assessment and determination has been completed by the U.S. Drug Enforcement Administration, which routinely occurs after FDA approval. The company is continuing with plans to seek approval for suvorexant in other countries around the world.