logo
Plus   Neg
Share
Email

Chelsea To Discuss NORTHERA NDA For Treatment Of Symptomatic Neurogenic OH

Chelsea Therapeutics International, Ltd. (CHTP) said it will meet with the Food and Drug Administration's, or FDA's, Cardiovascular and Renal Drugs Advisory Committee on February 23, 2012 to review clinical data in support of the New Drug Application, or NDA, for NORTHERA (droxidopa).

Chelsea is seeking approval of NORTHERA for treating symptomatic neurogenic orthostatic hypotension, or Neurogenic OH, in patients with primary autonomic failure, dopamine beta hydroxylase deficiency and non-diabetic autonomic neuropathy.

Dr. Simon Pedder, president and CEO of Chelsea, stated, "We have closely reviewed the materials prepared by the FDA, and look forward to presenting our clinical data to the Advisory Committee, which we believe will address the questions raised by the FDA. We believe that our clinical program has established robust safety and efficacy data for NORTHERA in this patient population."

by RTTNews Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Shares of Deutsche Bank were losing around 2 percent in German trading after the banking giant reported lower profit and revenues in its first quarter with weakness in all segments, mainly Corporate & Investment Bank. Separately, the bank announced actions to reshape its Corporate & Investment Bank and additional cost-cutting measures, including job cuts. Hershey Co. (HSY) on Thursday reaffirmed its adjusted earnings guidance for the full-year 2018 in the range of $5.33 to $5.43 range, an increase of 14 to 16 percent from 2017. However, reported earnings are now expected to be in the range of $4.73 to $4.98 per share, an increase of $0.02 per share... Automaker General Motors Co. on Thursday reported a 60 percent fall in profit for the first quarter from last year, reflecting lower revenues and a charge related to the company's Korean operations restructuring. However, adjusted earnings per share for the quarter beat analysts' estimates and the company affirmed its financial outlook for fiscal 2018.
Follow RTT