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
European Court of Justice in Luxembourg has canceled the international agreement between European Union and United States to handover digital information, such as web search histories and social media updates. The ruling will be a blow to tech giants Google, Microsoft, Facebook, Amazon, etc. Volkswagen Australia Wednesday confirmed that more than 91 thousand vehicles sold in Australia were fitted with emission cheating software. Volkswagen brand alone comes to 77,000 cars and 14,000 cars are Audis. In what could be a delectable offering, something is cooking in the brewing industry. Belgian brewer Anheuser-Busch Inbev, which in itself is an outcome of many mergers in the past, has made advances to U.K.'s SABMiller. If AB InBev succeeds in its pursuit, the heady combination of the two could create one of the world's largest brewers.
comments powered by Disqus
Follow RTT