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FDA Panel Recommends Approval Of Chelsea Therapeutics' Northera

Chelsea Therapeutics International Ltd.(CHTP) announced that the Food and Drug Administration's Cardiovascular and Renal Drugs Advisory Committee or CRDAC voted 7-4 with 1 abstention and 1 non-vote to recommend approval of Northera (droxidopa) for the treatment of symptomatic neurogenic orthostatic hypotension 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.

A Prescription Drug User Fee Act (PDUFA) action date for the Northera NDA has been scheduled for March 28, 2012.

by RTT Staff Writer

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