Chelsea Therapeutics, Inc. Completes End-of-Review Meeting With FDA for Northera(TM) (droxidopa) Capsules New Drug Application
Published: May 22, 2012
CHARLOTTE, N.C., May 22, 2012 (GLOBE NEWSWIRE) -- Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) completed an End-of-Review meeting with the U.S. Food and Drug Administration's (FDA) for its Northera™ (droxidopa) Capsules New Drug Application (NDA), and has received the official FDA minutes from the meeting. Chelsea requested the End-of-Review meeting following receipt of a complete response letter (CR Letter) in March 2012 indicating that its application was not ready for approval in its current form. Chelsea is seeking approval of Northera for the treatment of symptomatic neurogenic orthostatic hypotension (known as Neurogenic OH) 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.