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Novo Nordisk A/S Receives Complete Response Letter in United States for Tresiba and Ryzodeg

Sunday, 10 Feb 2013 03:09pm EST 

Novo Nordisk A/S announced that on February 8, 2013 it received a Complete Response Letter from the United States 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. In the letter, the FDA requests additional cardiovascular data from a dedicated cardiovascular outcomes trial before the review of the New Drug Applications can be completed. The Company is evaluating the content of the Complete Response Letter and will work closely with the FDA to provide the requested data. The Company does not expect to be able to provide the requested data during 2013. In the letter, the FDA also states that approvals for Tresiba and Ryzodeg cannot be granted until the violations cited in the previously announced Warning Letter, dated December 12, 2012, have been resolved. The New Drug Applications for Tresiba and Ryzodeg were submitted by Novo Nordisk to the FDA in September 2011. In November 2012, at an FDA Endocrinologic and Metabolic Drugs Advisory Committee meeting, a panel of independent scientific experts unanimously recommended that a cardiovascular outcomes trial should be conducted and voted eight to four in favor of approving the products with a post-approval cardiovascular outcomes trial commitment. 

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