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 (mailto:krsp@novonordisk.com) |
| Ken Inchausti (US) | +1 609 786 8316 | kiau@novonordisk.com (mailto:kiau@novonordisk.com) |
| Investors: | ||
| Peter Hugreffe Ankersen | +45 3075 9085 | phak@novonordisk.com (mailto:phak@novonordisk.com) |
| Melanie Raouzeos | +45 3075 3479 | mrz@novonordisk.com (mailto:mrz@novonordisk.com) |
| Hanna Ögren | +45 3079 8519 | haoe@novonordisk.com (mailto:haoe@novonordisk.com) |
| Kasper Veje (US) | +1 609 235 8567 | kpvj@novonordisk.com (mailto:kpvj@novonordisk.com) |
Company announcement no. 60/2016 (http://hugin.info/2013/R/2039453/760202.pdf)
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Source: Novo Nordisk A/S via Globenewswire
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
© 2016 GlobeNewswire (Europe)
