logo
Share SHARE
FONT-SIZE Plus   Neg

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 RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Maternity leave is a temporary period of absence from employment granted to expectant or new mothers during the months immediately before and after their pregnancy. Parental leave, including maternity, paternity and adoption leave, is an employee benefit. Many countries around the world, including... Texas, the second largest state in the U.S., has four of the five fastest-growing cities in the U.S., according to new population estimates released Thursday by the U.S. Census Bureau for the twelve months up to July 1, 2016. Ten of the fifteen fastest growing large U.S. cities during that 12-month span were in the South, according to the Census Bureau. To book-lover's surprise, online retailer Amazon opened another bricks and mortar store in an upmarket shopping mall in New York. This is the seventh book store of Amazon.
comments powered by Disqus
Follow RTT