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HOME > Analysis >Story Stocks >Novo Nordisk shares plunge...
Story Stocks® Archive
Last Update: 11-Feb-13 07:47 ET
Novo Nordisk shares plunge 13% following NDA letter requesting additional data
Novo Nordisk (NVO $167.00 -25.29) announced that it received a Complete Response Letter from the FDA regarding the New Drug Applications for Tresiba and Ryzodeg. 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. Novo Nordisk is evaluating the content of the Complete Response Letter and will work closely with the FDA to provide the requested data. Novo Nordisk 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 Complete Response Letter is not expected to significantly impact co's expectations for the financial results for 2013.
Novo Nordisk (NVO $167.00 -25.29) announced that it received a Complete Response Letter from the FDA regarding the New Drug Applications for Tresiba
 
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