22 March 2021 - Novo Nordisk today announced that the US FDA has issued a refusal to file letter covering the label expansion application for once-weekly semaglutide 2 mg for the treatment of type 2 diabetes which was filed on 20 January 2021. 

In the letter, FDA has requested additional information including data relating to a proposed new manufacturing site. While additional information needs to be included in the resubmission, Novo Nordisk believes the already completed clinical trial programme will be sufficient for approval of the label expansion application.

Read Novo Nordisk press release