Chelsea Therapeutics Submits Additional Information For Northera NDA

(RTTNews) - Chelsea Therapeutics International Ltd. (CHTP) Wednesday said it submitted to the U.S. Food and Drug Administration or FDA, additional information to clear certain technical deficiencies in its resubmitted New Drug Application or NDA for Northera (droxidopa).

Pending confirmation by the FDA, the resubmission is expected to be deemed a complete response to the March 28, 2012 Complete Response Letter issued by the agency, the company said.

Northera (droxidopa) is an investigational agent in Chelsea Therapeutics' pipeline. It is currently in Phase III development for the treatment of symptomatic neurogenic orthostatic hypotension in patients with primary autonomic failure, which is an indication that includes some patients with Parkinson's disease, multiple system atrophy and pure autonomic failure.