Quick Facts
FONT-SIZE Plus   Neg
Share SHARE

FDA Panel Recommends Approval Of Chelsea Therapeutics' Northera

Chelsea Therapeutics International Ltd.(CHTP: Quote) announced that the Food and Drug Administration's Cardiovascular and Renal Drugs Advisory Committee or CRDAC voted 7-4 with 1 abstention and 1 non-vote to recommend approval of Northera (droxidopa) for the treatment of symptomatic neurogenic orthostatic hypotension 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 March 28, 2012.

Click here to receive FREE breaking news email alerts for Chelsea Therapeutics International and others in your portfolio

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
This apparel maker has doubled its earnings per share in just two years and regularly increasing its annual earnings forecast, despite a challenging consumer spending environment. Contributions from acquisitions, efficiency gains from self-owned global supply chain and benefits from 'Innovate-to-Elevate' strategy continue to boost the company's top-line and bottom-line results. Here is a quick summary of the earnings reported after the bell on Nov 20. We have 20+ stocks listed here. The good news is you can skip this step. There is a next move that can make your life a lot easier. Our research team has already done the groundwork for you. All these stocks listed... Design software maker Autodesk, Inc. said Thursday after the markets closed that its third quarter profit fell 81% from last year, as higher costs and expenses more than offset an 11% increase in revenue. However, the company's quarterly earnings per share, excluding items, came in above analysts' expectations as did its quarterly revenue.
comments powered by Disqus
FREE Newsletters, Analysis & Alerts

 

Stay informed with our FREE daily Newsletters and real-time breaking News Alerts. Sign up to receive the latest information on business news, health, technology, biotech, market analysis, currency trading and more.