Reuters: Regulatory News: FDA delays decision on Novo Nordisk's degludec

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FDA delays decision on Novo Nordisk's degludec Jul 18th 2012, 07:59 COPENHAGEN, July 18 | Wed Jul 18, 2012 3:59am EDT COPENHAGEN, July 18 (Reuters) - U.S. health regulators have postponed a decision on approval of Danish drugmaker Novo Nordisk's ultra-long-acting insulin degludec, from an earlier expected date in late October, to allow for a review by outside experts, the company said on Wednesday. The U.S. Food and Drug Administration had said in June it would decide on a new drug application for degludec and degludec in combination with insulin aspart on Oct. 29. But the FDA has now said that a further advisory committee meeting will be held on Nov. 8. "In its communication about the advisory committee meeting the agency has not informed Novo Nordisk of a new action date," Novo Nordisk said. The company submitted the new drug applications to the FDA on Sept. 29.

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