Novo Nordisk receives Complete Response Letter in the US for Tresiba® and Ryzodeg®

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

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