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."
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