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FDA Stays Complete Response on Chelsea’s Northera NDA, Pans Amended Data Plan
The FDA has notified Chelsea Therapeutics that its proposal for using initial results from an ongoing clinical trial of its Northera neurogenic orthostatic hypotension (NOH) drug is not enough to undo the complete response letter it received in March, the orphan-drug maker says. In a recent “advice letter” to Chelsea, the agency restated its position that an additional efficacy study will be necessary to support approval, the Charlotte, N.C.-based innovator said Tuesday.
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