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.
Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat other serious chronic conditions: haemophilia, growth disorders and obesity. Headquartered in Denmark, Novo Nordisk employs approximately 42,300 people in 75 countries and markets its products in more than 180 countries. Novo Nordisk's B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit novonordisk.com, Facebook, Twitter, LinkedIn, YouTube
Further informationMedia: | ||
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 |
Investor Relations
Novo Allé
2880 Bagsværd Denmark
Telephone:
+45 4444 8888
Internet: www.novonordisk.com CVR no:
24 25 67 90
Company announcement No 60 / 2016
Novo Nordisk A/S published this content on 03 September 2016 and is solely responsible for the information contained herein.
Distributed by Public, unedited and unaltered, on 05 September 2016 07:15:04 UTC.
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