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.

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