FDA to review Chelsea Therapeutics' drug for symptomatic NOH

07/19/2013 | Pharmaceutical Business Review Online

The FDA has accepted Chelsea Therapeutics' application to market Northera, or droxidopa, as a treatment for symptomatic neurogenic orthostatic hypotension in patients with primary autonomic failure, non-diabetic autonomic neuropathy and dopamine beta hydroxylase deficiency. "We will continue to work closely with the FDA toward an approval decision for Northera by early next year, and advance our commercial strategy in anticipation of a U.S. commercial launch soon after this," Chelsea's interim CEO, Joseph Oliveto, said.

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