Trials & Filings

NOH Treatment To Get Advisory Review

Chelsea's Northera to be reviewed in January 2014

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Chelsea Therapeutics International‘s treatment for symptomatic neurogenic orthostatic hypotension (NOH), Northera (droxidopa), will be reviewed by the FDA’s Cardiovascular and Renal Drug Advisory Committee (CRDAC). The meeting is tentatively scheduled for January 14, 2014. Northera is an orally active synthetic precursor of norepinephrine The FDA recently assigned to Northera a Prescription Drug User Fee Act (PDUFA) goal date of February 14, 2014. Northera was previously granted Orp...

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