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Press Release

FDA extends regulatory review period for IDegLira by three months

Novo Nordisk A/S
Posted on: 02 Sep 16

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.

Further information
Media:   
Katrine Sperling+45 3079 6718 krsp@novonordisk.com
Ken Inchausti (US)+1 609 786 8316 kiau@novonordisk.com
 

Investors:
  
Peter Hugreffe Ankersen+45 3075 9085 phak@novonordisk.com
Melanie Raouzeos+45 3075 3479 mrz@novonordisk.com
Hanna Ögren+45 3079 8519 haoe@novonordisk.com
Kasper Veje (US)+1 609 235 8567  kpvj@novonordisk.com

 

Company announcement no. 60/2016


This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX Corporate Solutions clients.

The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.

Source: Novo Nordisk A/S via GlobeNewswire
HUG#2039453
GlobeNewswire
globenewswire.com

Last updated on: 03/09/2016

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