Tuesday, July 30, 2013

FDA postpones hypotension treatment candidate review over technical problems

The AP (7/30) reports Chelsea Therapeutics International Ltd. announced Monday that there has been “another delay in the review” of its experimental neurogenic orthostatic hypotension treatment, Northera (droxidopa). Chelsea said the Food and Drug Administration told the company that problems were found with the “formatting of electronic datasets and statistical programs describing the methods that were used to generate tables and listings.” The Charlotte, North Carolina-based pharmaceutical firm “said it expects to send a response to the FDA in August.” The AP notes that initially, the agency was slated to make a decision on whether to approve the treatment by Jan. 3, but the delay makes it more likely that a ruling will be made in February.

        In its coverage of the FDA response, the Wall Street Journal (7/30, Stynes, Subscription Publication, 2.29M) notes that Northera, which Dainippon Sumitomo Pharma Company developed, has been approved in Japan since 1989. Bloomberg News (7/30, Izlar) also covers the story.

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