Will the FDA Approve Chelsea Therapeutics, Inc.'s Northera?

The third Food and Drug Administration decision in three days is scheduled for tomorrow, when the agency is scheduled to decide on the fate of Chelsea Therapeutics' (NAS: CHTP) Northera, a treatment for neurogenic orthostatic hypotension, or NOH. The advisory panel recommended approval of the drug by a margin of 7-4, with one panelist abstaining and another deciding not to vote at all. Despite the positive recommendation, clearly the panel wasn't gung-ho about approving the drug, which will weigh on the agency that was already questioning the safety profile before the meeting.

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