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High-Dose Ozempic Filing Refused by FDA
Novo Nordisk announced it received a Refusal to File letter from FDA regarding the sNDA for high-dose 2.0mg injectable semaglutide. Recall, Novo initially filed the application with FDA on January 20, 2021 (previous FENIX insight). Novo plans to re-file in Q2 ’21. Below, FENIX provides thoughts on the high-dose semaglutide delay in the context of Lilly’s high-dose Trulicity and tirzepatide assets.