Chelsea Therapeutics International Ltd (CHTP: Quote) Tuesday announced that it has completed an End-of-Review meeting with the U.S. Food and Drug Administration, or the FDA, in connection with its New Drug Application, or NDA, for Northera Capsules.
The company stated that it has requested for an End-of-Review meeting with the FDA after receiving the complete response letter from FDA in March 2012 indicating that its application was not ready for approval in its current form.
The company has been seeking approval of Northera for the treatment of symptomatic neurogenic orthostatic hypotension in patients with primary autonomic failure, dopamine beta hydroxylase deficiency and non-diabetic autonomic neuropathy.
Dr.Simon Pedder, President and CEO of the company said : "We appreciate the FDA's thorough review of both our application and initial proposal. Through these discussions, we believe we have garnered a more complete understanding of the issues raised in the CR Letter and are working to finalize our plans to modify our ongoing Study 306B with the intent of resubmitting the Northera NDA in the first quarter of 2013."
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by RTT Staff Writer
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