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Aug 05, 2013
 |  BC Week In Review  |  Clinical News  |  Regulatory

Northera droxidopa regulatory update

Chelsea said FDA will delay the 6-month PDUFA review period for Northera droxidopa to treat symptomatic neurogenic orthostatic hypotension (NOH) until the biotech addresses technical deficiencies identified in a resubmitted NDA. Chelsea said it expects to submit a response this month. In July, the agency accepted the resubmitted NDA and assigned the application a Jan. 3,...

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