FDA Feedback for Novo Nordisk's Liraglutide Delayed Until 4th Quarter of 2009
Wed, 09/23/2009 - 4:35am
Novo Nordisk today announced that formal feedback from the FDA regarding liraglutide, a once-daily human GLP-1 analogue, has been deferred until the fourth quarter of 2009. Novo Nordisk continues the constructive dialogue with the FDA regarding the regulatory process for liraglutide. Novo Nordisk expects to provide an update on the regulatory process for liraglutide in connection with the announcement of the financial results for the first nine months of 2009, on 29 October 2009, if formal feedback is not received before then. This update on the timeline for formal feedback on liraglutide from the FDA does not change Novo Nordisk's expectations for the company's financial results for 2009, which were provided on 6 August in connection with the release of the financial results for the first six months of 2009.