logo
Share SHARE
FONT-SIZE Plus   Neg

FDA Panel Recommends Approval Of Chelsea Therapeutics' Northera

Chelsea Therapeutics International Ltd.(CHTP) 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.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Tech giant Apple Inc. has developed a new technology that will prohibit audiences using their iPhones to record concerts. The Cupertino, California-based company has secured a patent in the US for its new technology. The technology uses infrared signals to shut down cameras on audience members' smartphones. The... Snacks giant Mondelez International Inc. (MDLZ) made a takeover bid of $23 billion to acquire chocolate behemoth Hershey Co. (HSY) that would create the world's largest chocolate company. Nevertheless, shares of Hershey jumped over 15 percent after the company revealed that it has rejected the offer. "The... Mortgage rates dropped this week to the lowest level in more than three years hurt by the UK's shocking decision to exit European Union. Releasing the results of its primary mortgage market survey, Freddie Mac said that the 30-year fixed-rate mortgage or FRM averaged 3.48 percent for the week ended...
comments powered by Disqus
Follow RTT