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GLP-1RA

May 28, 2021

Novo Resubmits 2.0mg High-dose Ozempic to FDA

Here is a brief preview of this blast: Novo Nordisk announced it has resubmitted the sNDA to FDA for QW high-dose 2.0mg injectable semaglutide for the treatment of T2DM. Recall, in March 2021, Novo announced it received a Refusal to File letter from FDA (previous FENIX insight) after initially filing the application on January 20, 2021 (previous FENIX insight). Below, FENIX provides thoughts on the refiling.