Novo Nordisk
2013-02-10T20:11:19Z
2013-02-10T20:11:19Z
Novo Nordisk receives Complete Response Letter in the US for Tresiba® and Ryzodeg®
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