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FDA postpones Novo-approval once again

Registration applications for Novo Nordisk’s ultra-long-acting insulin analogs will be discussed at an FDA-meeting in November.

Foto: Novo Nordisk/PR

After the 8th of November Novo Nordisk will know a lot more about the commercial potential of their ultra-long-acting insulin analogs, as FDA has scheduled a meeting in the advisory committee to discuss the drugs Degludec (Tresiba) and Degludecplus.

“The 8th of June this year the FDA announced that the updated date of action will be the 29th of October 2012. In the announcement of the meeting in the advisory committee, FDA has not informed Novo Nordisk about a new date,” the company writes in a statement.

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