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 [email protected]
Lori Moore +1 609 919 7991 [email protected]
Investors:
Kasper Roseeuw Poulsen +45 4442 4303 [email protected]
Frank Daniel Mersebach +45 4442 0604 [email protected]
Lars Borup Jacobsen +45 3075 3479 [email protected]
Jannick Lindegaard (US) +1 609 786 4575 [email protected]
Company announcement No 11 /2013