Xultophy
Generic name: insulin degludec and liraglutide
Treatment for: Diabetes, Type 2
FDA Extends Regulatory Review Period for IDegLira by Three Months
Bagsværd, Denmark, 2 September 2016 - Novo Nordisk today announced that the US Food and Drug Administration (FDA) has extended the regulatory review period for IDegLira, the fixed-ratio combination of insulin degludec and liraglutide in adults with type 2 diabetes.
The FDA informed Novo Nordisk that a three-month extension was required in order to complete its review of the new drug application (NDA) for IDegLira.
Novo Nordisk submitted the NDA to the FDA in September 2015, and with the extension of the review the action date is now expected in December 2016.
Source: Novo Nordisk
Posted: September 2016
Related articles
- Novo Nordisk Receives FDA Approval for Xultophy 100/3.6 (insulin degludec and liraglutide injection) for Type 2 Diabetes - November 21, 2016
- IDegLira Receives Positive 16-0 Vote in Favour of Approval from FDA Advisory Committee - May 24, 2016
Xultophy (insulin degludec and liraglutide) FDA Approval History
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