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Novo Nordisk, Sanofi Insulin Combo Products Clear US Regulatory Hurdles

 
• By Sue Sutter

US FDA approves Xultophy and Soliqua, both fixed-ratio combinations of a basal insulin and a GLP-1 agonist, on the same day even though Sanofi redeemed a priority review voucher that earned Soliqua an earlier user fee goal date.

Soliqua InsulinPen 100/33

Novo Nordisk AS' and Sanofi's respective basal insulin/GLP-1 agonist fixed-ratio combination products, Xultophy and Soliqua, gained FDA approval Nov. 21 with narrower indications and different labeling than originally proposed.

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