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Dura Pharmaceuticals

Executive Summary

FDA cites Dura for insufficient information in its Nov. 4 press release on a "not approvable" letter for its albuterol AlSpiros inhaler. "The overall promotional message of the press release misleadingly minimizes the fact that Dura must conduct a completely new clinical trial program for the redesigned to-be-marketed product," the FDA letter states, emphasizing that "these clinical trials (12 weeks and one-year open label) must be conducted prior" to FDA's reconsideration of the product. The agency requested that Dura specifically ask for the removal of the press release from the PRNewswire website
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PS033246

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