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Feb 25, 2013
 |  BC Week In Review  |  Clinical News  |  Regulatory

Northera droxidopa regulatory update

Chelsea said it will resubmit an NDA for Northera droxidopa to treat symptomatic neurogenic orthostatic hypotension (NOH) in late 2Q13 after FDA said data from the company's Phase III Study 306B trial may be sufficient as the basis of the resubmission. Last March, FDA issued a complete response letter for Northera requesting data from an additional trial to show durability of effect over a 2-3 month period.

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