(By Balachander) Novo Nordisk (NYSE: NVO) said the U.S. health regulators would not approve the Denmark-based drug maker's new drug applications (NDA) for insulin Tresiba and Ryzodeg.
American depositary receipts (ADRs) of NVO plunged 12.26 percent in premarket trading on Monday.
In a Complete Response Letter, the US Food and Drug Administration (FDA) requests additional cardiovascular data from a dedicated cardiovascular outcomes trial before the review of the NDAs can be completed.
Novo Nordisk said it does not expect to be able to provide the requested data during 2013.
The company said it was evaluating the content of the Complete Response Letter and will work closely with the FDA to provide the requested data.
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The NDAs for Tresiba and Ryzodeg were submitted by the company to the FDA in September 2011.
Tresiba and Ryzodeg are approved in Japan, the EU and Mexico and under regulatory review in a number of countries throughout the world.
ADRs have been trading in the 52-week range of $129.41 to $194.44.