CHARLOTTE, N.C., Nov. 17, 2011 (GLOBE NEWSWIRE) -- Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP - News) announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for NORTHERA(TM) (droxidopa), an orally active synthetic precursor of norepinephrine, for the treatment of symptomatic neurogenic orthostatic hypotension (NOH) in patients with primary autonomic failure (Parkinson’s disease, multiple system atrophy and pure autonomic failure), dopamine beta hydroxylase deficiency and non-diabetic autonomic neuropathy. The FDA also granted Chelsea’s request for Priority Review, and, under the Prescription Drug User Fee Act (PDUFA), the FDA’s goal is to review and act on the NDA by March 28, 2012. The FDA grants priority review to drugs offering major advances in treatment, or providing a treatment where no adequate therapy exists.
