Arbor Pharmaceuticals, LLC, a U.S.-based specialty pharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has accepted for filing its New Drug Application (NDA) for AR19, an investigational immediate-release, amphetamine capsule for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children three through 17 years of age and in adults 18 and older. AR19 has been specifically designed to resist potential manipulation. The FDA has set a Prescription Drug User Fee Act target action date of November 15, 2020.
The AR19 NDA is supported by a comprehensive clinical program including studies that support the compound’s safety and efficacy for the treatment of children and adults and its manipulation-resistant properties. Arbor Pharmaceuticals markets three ADHD treatments and is developing several potential new treatment options including AR19.
Arbor Pharmaceuticals, headquartered in Atlanta, Georgia, is a specialty pharmaceutical company currently marketing FDA-approved prescription products in the neuroscience, cardiovascular, and hospital markets. In addition to an extensive pipeline, the company continues to actively pursue growth through acquisition or licensing of late-stage development products.
This was reported by Arbor Pharmaceuticals on May 13, 2020.
Contact information: Arbor Pharmaceuticals, LLC, Six Concourse Parkway, Suite 1800, Atlanta, Georgia 30328; 678-334-2420; Website: https://arborpharma.com/