Novo Nordisk announced that the FDA issued a refusal-to-file letter related to its application to expand the label for once-weekly subcutaneous Ozempic (semaglutide).
The company had sought to expand the label for a 2.0-mg dose of once-weekly semaglutide to treat type 2 diabetes. It filed the letter on Jan. 20, 2021.
The letter indicates that FDA has concluded additional information is needed to review an application.
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