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APPROVAL AT LAST

Chelsea Therapeutics’ Northera wins FDA nod in NOH; black-box warning in label

By Randy Osborne
Staff Writer

Tuesday, February 18, 2014
The long, hazard-fraught road for Chelsea Therapeutics International Ltd. with Northera (droxidopa) – including unfavorable briefing documents, followed by a positive advisory committee (adcom) vote – came to a happy end with approval of the drug by the FDA for neurogenic orthostatic hypotension (NOH), or a sudden drop in blood pressure when the patient stands up.

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