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
Reports that Gary Cohn is considering resigning as President Donald Trump's top economic advisor have weighed on Wall Street, although the White House has denied the claims. Cohn, former president and chief operating officer of Goldman Sachs (GS), currently serves as the Director of the National Economic Council. A Pennsylvania woman has sued Chick-fil-A after she claimed a dead rodent was found baked into her chicken sandwich. Ellen Manfalouti of Northampton has filed a lawsuit in Bucks County Court against Chick-fil-A, seeking more than $50,000 for the physical and psychological damages that she endured after the incident occurred. Early Uber investor Shervin Pishevar has alleged that venture capital firm Benchmark Capital is seeking to remove Arianna Huffington from the ride-hailing company's board of directors. Pishevar also accused Benchmark of holding Uber hostage by threatening to block investments in the company and urged it to step down from Uber's board of directors.
comments powered by Disqus
Follow RTT