US FDA further delays Chelsea's Northera
US biotech firm Chelsea Therapeutics (Nasdaq: CHTP) has received acknowledgment of its resubmitted New Drug Application to the US Food and Drug Administration (FDA) to market Northera (droxidopa) for the treatment of symptomatic neurogenic orthostatic hypotension (NOH).
The FDA has deemed the resubmission a complete response to its March 28 Complete Response Letter and assigned a new Prescription Drug User Fee Act (PDUFA) goal date of January 3, 2014 ( The Pharma Letter July 10).
The drug is indicated for use in patients with primary autonomic failure (Parkinson's disease, multiple system atrophy and pure autonomic failure), dopamine beta hydroxylase deficiency and non-diabetic autonomic neuropathy.
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