Novo nordisk receives refusal to file letter for once-weekly semaglutide 2.0 mg for the treatment of type 2 diabetes

BagsvÆrd, denmark, 22 march 2021 – novo nordisk today announced that the us food and drug administration (fda) has issued a refusal to file letter covering the label expansion application for once-weekly semaglutide 2.0 mg for the treatment of type 2 diabetes which was filed on 20 january 2021. a refusal to file letter is received when the fda determines additional information is required to review a complete application.
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