Chelsea Therapeutics (CHTP) Completes End-of-Review Meeting with FDA Over Northera NDA
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Chelsea Therapeutics International, Ltd. (Nasdaq: CHTP) completed an End-of-Review meeting with the U.S. Food and Drug Administration's (FDA) for its Northera (droxidopa) Capsules New Drug Application (NDA), and has received the official FDA minutes from the meeting. Chelsea requested the End-of-Review meeting following receipt of a complete response letter (CR Letter) in March 2012 indicating that its application was not ready for approval in its current form. Chelsea is seeking approval of Northera for the treatment of symptomatic neurogenic orthostatic hypotension (known as Neurogenic OH) in patients with primary autonomic failure (Parkinson's disease, multiple system atrophy and pure autonomic failure), dopamine beta hydroxylase deficiency and non-diabetic autonomic neuropathy.
"Over the past month, we have had several informative interactions with the FDA, including our recent end-of-review meeting, to more fully understand the FDA's concerns regarding our new drug application for Northera," commented Dr. Simon Pedder, president and CEO of Chelsea Therapeutics. "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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"Over the past month, we have had several informative interactions with the FDA, including our recent end-of-review meeting, to more fully understand the FDA's concerns regarding our new drug application for Northera," commented Dr. Simon Pedder, president and CEO of Chelsea Therapeutics. "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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