Chelsea Therapeutics: FDA Accepts Northera NDA Resubmission - Quick Facts

(RTTNews) - Chelsea Therapeutics International Ltd. (CHTP) announced that the U.S. Food and Drug Administration or FDA has acknowledged receipt of the New Drug Application or NDA resubmission seeking approval to market Northera (droxidopa), an orally active synthetic precursor of norepinephrine, for the treatment of symptomatic neurogenic orthostatic hypotension or NOH 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.

The FDA has deemed the resubmission a complete response to its March 28, 2012 Complete Response Letter and assigned a new Prescription Drug User Fee Act (PDUFA) goal date of January 3, 2014, the company said.

"FDA acknowledgement of the completeness of our NDA resubmission is another key milestone in reaching this goal. We will continue to work closely with the FDA toward an approval decision for Northera by early next year, and advance our commercial strategy in anticipation of a U.S. commercial launch soon after this," said Joseph Oliveto, Interim Chief Executive Officer of Chelsea.