FDA Advisory Panel Recommends Approval of Chelsea Therapeutics’ NORTHERA(TM) (Droxidopa) for the Treatment of Symptomatic nOH
CHARLOTTE, N.C., Jan. 14, 2014 (GLOBE NEWSWIRE) — Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) today announced that the Food and Drug Administration’s (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted 16-1 to recommend approval of NORTHERA(TM) (droxidopa) 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 is not bound by the CRDAC’s recommendation but will take it into consideration when reviewing the New Drug Application (NDA) for Northera. A Prescription Drug User Fee Act (PDUFA) action date for the Northera NDA has been scheduled for February 14, 2014.
“Chelsea is committed to improving the lives of patients with nOH, a debilitating disorder which often severely limits a person’s ability to perform routine daily activities,” said Joseph G. Oliveto, Interim Chief Executive Officer of Chelsea Therapeutics. “We are appreciative of the FDA bringing our Northera NDA before the Cardiovascular and Renal Drugs Advisory Committee, and for the Committee’s thoughtful discussion of the application.” Read the rest of the article at http://online.wsj.com/article/PR-CO-20140114-910624.html