Atlanta, GA – Arbor Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing its second New Drug Application (NDA). The NDA was originally filed with the FDA on December 23, 2013 and officially accepted for filing on February 23, 2014. Arbor’s first NDA, Nymalize® (nimodipine) oral solution, was approved in May of last year.
Arbor has a total of seven other branded projects in development consisting of both 505(b)(1) and 505(b)(2) type filings. One of these projects is in phase three clinical development and three are currently in phase two studies. In addition to these NDAs, Arbor has ten Abbreviated New Drug Applications (ANDAs) filed with the FDA through its Wilshire generic division or one of our partner companies. Wilshire also has an additional 25 ANDAs in various stages of development.
Ed Schutter, President & CEO of Arbor stated, “I am pleased with the progress of both our branded and generic development pipeline. We believe this most recent NDA filing meets an unmet medical need and has the potential to improve pharmacotherapy for certain patients.”
Dr. Laurence Downey, VP of Medical & Scientific Affairs added, “I would like to congratulate the R&D team who ensured the timely submission of our second NDA. When approved, this product will make an important addition to patient care.”
Arbor Pharmaceuticals has been assigned a Prescription Drug User Fee Approval date (PDUFA) of October 23, 2014 for this NDA.
ABOUT ARBOR PHARMACEUTICALS
Arbor Pharmaceuticals, headquartered in Atlanta, Georgia, is a specialty pharmaceutical company currently focused on the hospital, cardiovascular and pediatric markets. The company has 280 sales professionals in the field which promote its products to hospitals and physicians. Arbor intends to become a leading specialty pharmaceutical company by actively licensing, developing and commercializing late-stage products for specialty focused conditions. Arbor currently markets sixteen NDA and ANDA approved products with over thirty more in development.