Chelsea Therapeutics International, Ltd. (CHTP) announced that the U.S. Food and Drug Administration, or FDA, has accepted for filing the New Drug Application, or NDA, for NORTHERA (droxidopa), an orally active synthetic precursor of norepinephrine, for the treatment of symptomatic neurogenic orthostatic hypotension in patients with primary autonomic failure, dopamine beta hydroxylase deficiency and non-diabetic autonomic neuropathy.
In addition, the FDA 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.
Dr. Simon Pedder, president and CEO of Chelsea Therapeutics, said, "We are confident that our Phase III data clearly establish the safety and efficacy of Northera for the treatment of the signs and symptoms of neurogenic orthostatic hypotension, and look forward to continuing to work with FDA during their review of our Northera application and having the opportunity to present our data to an advisory committee."
For comments and feedback: editorial@rttnews.com