FDA extends regulatory review period for IDegLira by three months
2016-09-02 · Novo Nordisk A/S · original novonordisk.com ↗
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 [email protected] Ken Inchausti (US) +1 609 786 8316 [email protected] Investors: Peter Hugreffe Ankersen +45 3075 9085 [email protected] Melanie Raouzeos +45 3075 3479 [email protected] Hanna Ögren +45 3079 8519 [email protected] Kasper Veje (US) +1 609 235 8567 [email protected]
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