Arbor files first NDA with U.S. FDA

Arbor Pharmaceuticals announced today that it has filed its first New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA).  The recently filed product has been granted an Orphan designation by the FDA which provides seven years of market exclusivity. In addition, the FDA has granted Fast Track review status for this product primarily due to the safety advantages it offers. Fast Track review shortens the normal twelve month review period to six months. 

Ed Schutter, President & CEO of Arbor stated, "I am pleased that our first NDA filing could be accomplished so early in our brief company history. I am excited about the market potential for this product as well as our other products in development. We could not have accomplished this without the leadership and dedication of Dr. Downey and his team."

Dr. Laurence Downey, VP of Medical & Scientific Affairs added, "Filing of our initial NDA with the FDA is an important milestone in the evolution of Arbor Pharmaceuticals. This is the first of what we hope will be multiple NDA filings over the next several years. I would like to thank and congratulate our team that worked tirelessly to file this submission on a timely basis."

Arbor has over 130 sales professionals in the field which promote its products to hospitals and physicians.  The company expects to launch the new product to the hospital market in mid-2012. Arbor continues to actively seek other marketed and late stage products to acquire in this segment as well as other specialty focused areas complementary to its business.