January 27, 2020
Corium, Inc. Announces FDA Filing Acceptance of New Drug Application for ADLARITY® (donepezil transdermal system) for the Treatment of Alzheimer’s Disease
MENLO PARK, Calif., January 27, 2020 (GLOBE NEWSWIRE) – Corium, Inc., a commercial-stage biopharmaceutical company leading the development of novel transdermal healthcare products that are intended to provide alternative treatment options for patients and their families, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the company’s New Drug Application (NDA) for ADLARITY (donepezil transdermal system), its lead investigational agent for the treatment of dementia of the Alzheimer’s type in patients with mild, moderate, and severe Alzheimer’s disease. FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of July 30th, 2020.