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Northera Under FDA Review

Oct 15, 2013

Nasdaq

The Cardiovascular and Renal Drug Advisory Committee of the U.S. Food and Drug Administration (FDA) will review the New Drug Application (NDA) Chelsea Therapeutics International, Ltd. filed for Northera in Jul 2013. The meeting is scheduled to take place on Jan 14, 2014.

Chelsea Therapeutics is looking to get Northera approved 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). The FDA's decision on the approval of Northera is expected by Feb 14, 2014.Northera has both orphan drug designation and fast track designation in the U.S. Read the full story