Chelsea seeks approval for neurogenic orthostatic hypotension drug

Filing marks company's first with FDA

CHARLOTTE, N.C. — Chelsea Therapeutics International has applied for Food and Drug Administration approval of a drug for a disorder that affects patients with diseases like Parkinson's disease.

The drug maker announced the submission of a new drug application for Northera (droxidopa) as a treatment for neurogenic orthostatic hypotension. NOH predominantly affects people with primary autonomic failure, a group of diseases that includes Parkinson's, multiple system atrophy and pure autonomic failure.

Chelsea expects the FDA to decide whether or not to grant approval in first quarter 2012, the company said.

 


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