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Xultophy FDA Approval History

FDA Approved: Yes (First approved November 21, 2016)
Brand name: Xultophy
Generic name: insulin degludec and liraglutide
Dosage form: Injection
Previous Name: IDegLira
Company: Novo Nordisk
Treatment for: Diabetes, Type 2

Xultophy 100/3.6 (insulin degludec and liraglutide) is a fixed-ratio combination of the long-acting basal insulin analog, insulin degludec (Tresiba), and the a glucagon-like peptide-1 (GLP-1) receptor agonist liraglutide (Victoza), indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

Development timeline for Xultophy

Nov 21, 2016Approval Novo Nordisk Receives FDA Approval for Xultophy 100/3.6 (insulin degludec and liraglutide injection) for Type 2 Diabetes
Sep  2, 2016FDA Extends Regulatory Review Period for IDegLira by Three Months
May 24, 2016IDegLira Receives Positive 16-0 Vote in Favour of Approval from FDA Advisory Committee

Further information

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