Printer Friendly

Chelsea Therapeutics International Ltd awarded FDA's approval for NORTHERA for treating symptomatic neurogenic orthostatic hypotension.

M2 EQUITYBITES-January 15, 2014-Chelsea Therapeutics International Ltd awarded FDA's approval for NORTHERA for treating symptomatic neurogenic orthostatic hypotension

(C)2014 M2 COMMUNICATIONS http://www.m2.com

Biopharmaceutical company Chelsea Therapeutics International Ltd (NasdaqCM:CHTP) reported on Tuesday the receipt of the Food and Drug Administration's (FDA) approval of NORTHERA for the treatment of symptomatic neurogenic orthostatic hypotension (nOH), a chronic disorder that is caused by an underlying neurogenic disorder.

The company added the Food and Drug Administration's (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted 16-one to recommend approval of NORTHERA (droxidopa) for the treatment of symptomatic neurogenic orthostatic hypotension (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.

A Prescription Drug User Fee Act (PDUFA) action date for the Northera NDA has been scheduled for 14 February 2014, according to the company.

Currently, NORTHERA (droxidopa) is in Phase III development for the treatment of symptomatic neurogenic orthostatic hypotension (nOH) in patients with primary autonomic failure.

In addition, droxidopa is a synthetic catecholamine that is directly converted to norepinephrine (NE) via decarboxylation, resulting in increased levels of NE in the nervous system, both centrally and peripherally, concluded the company.

((Comments on this story may be sent to info@m2.com))

COPYRIGHT 2014 Normans Media Ltd.
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2014 Gale, Cengage Learning. All rights reserved.

Article Details
Printer friendly Cite/link Email Feedback
Publication:M2 EquityBites (EQB)
Date:Jan 15, 2014
Words:216
Previous Article:Aeropostale approaches at least two PE firms - report.
Next Article:Standard Chartered buys 13% in Botswana's retailer Choppies.
Topics:

Terms of use | Privacy policy | Copyright © 2018 Farlex, Inc. | Feedback | For webmasters