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

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

Suggested Articles

A TGen-led research team found that increased activity of the gene AEBP1 drives severe liver fibrosis in nonalcoholic steatohepatitis.

Days after announcing its R&D chief was stepping down, Gilead announced it will be buying a few of Novartis’ unwanted early-stage infection assets.

Mallinckrodt is teaming up with Silence Therapeutics to develop an RNAi program aimed at a group of proteins that play a part in promoting inflammation.