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Novo Nordisk receives Complete Response Letter in the US for Tresiba® and Ryzodeg® (10 February 2013)

Read the full announcement in PDF format

Bagsværd, Denmark, 10 February 2013 - Novo Nordisk today announced that on 8 February 2013 it received a Complete Response Letter from the US Food and Drug Administration (FDA) regarding the New Drug Applications for Tresiba® (insulin degludec) and Ryzodeg® (insulin degludec/insulin aspart). A Complete Response Letter is issued by the FDA, when the agency determines that an application cannot be approved in its current form.

Further information

Media:
Mike Rulis +45 3079 3573 mike@novonordisk.com
Lori Moore +1 609 919 7991 lrmo@novonordisk.com
Investors:
Kasper Roseeuw Poulsen +45 4442 4303 krop@novonordisk.com
Frank Daniel Mersebach +45 4442 0604 fdni@novonordisk.com
Lars Borup Jacobsen +45 3075 3479 lbpj@novonordisk.com
Jannick Lindegaard (US) +1 609 786 4575 jlis@novonordisk.com

Company announcement No 11 /2013

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