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

Editors Pick
Swiss banking giant UBS Group AG (UBS) reported Friday an increased pre-tax profit for the third quarter despite weakness in net interest income. Net profit, however, decreased on the absence of last year's hefty tax benefit. Looking ahead, UBS said it is unlikely that the underlying macroeconomic uncertainty and geopolitical tensions will change in the foreseeable future. Amazon.com Inc. (AMZN) Thursday reported an increase in profit for the third quarter, driven largely by revenue growth, especially at Amazon Web services. However, shares of the online retailer dropped nearly 5 percent in extended session after its profit fell short of Wall Street estimates. The midpoint... Alphabet Inc., (GOOG, GOOGL), the parent company of Google, Thursday reported a jump in third-quarter profit, largely driven by increase in search and advertising revenues. Earnings and revenues for the quarter trumped Wall Street expectations. Alphabet's third-quarter profit rose to $5.06 billion...
comments powered by Disqus
Follow RTT