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news.The Food and Drug Administration's (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) has recommended the approval of Chelsea's NORTHER (droxidopa) for the treatment of symptomatic neurogenic orthostatic hypotension (OH).
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Northera has received orphan drug designation from the FDA to treat rare diseases/disorders.
Neurogenic OH is a chronic neurogenic disorder resulting from deficient release of norepinephrine, the neurotransmitter used by sympathetic autonomic nerves to send signals to the blood vessels and the heart to regulate blood pressure.
Chelsea Therapeutics president and CEO Simon Pedder said the clinical data demonstrates the significant symptomatic benefit of Northera treatment across a broad range of Neurogenic OH symptoms.
"We are pleased by today’s panel vote and we look forward to continuing to work with the FDA in advance of the March 28, 2012 PDUFA action date," Pedder added.