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FDA Rejects Novo Nordisk's NDA for New Generation Insulin Drugs

by Kathy Jones on  February 11, 2013 at 6:06 PM Drug News   - G J E 4
Danish pharmaceutical company Novo Nordisk revealed that the new drug application (NDA) for its 'new generation' of insulin drugs, Tresiba and Ryzodeg, has been rejected by the US Food and Drug Administration.
 FDA Rejects Novo Nordisk's NDA for New Generation Insulin Drugs
FDA Rejects Novo Nordisk's NDA for New Generation Insulin Drugs
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Nordisk said that it has received a complete response from FDA, which the agency sends to pharmaceutical companies if it decides not to approve NDAs in its current form.

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The FDA has asked for additional data from a dedicated cardiovascular outcomes trial which Nordisk said that it will not be able to provide in 2013.

Stating that the company was disappointed on receiving the letter from the FDA, Nordisk CEO Lars Rebien Sorensen said, "We are convinced that Tresiba and Ryzodeg offer significant benefits for people who require insulin. We are surprised and disappointed to receive this letter, but we acknowledge this decision by the FDA and will work with the agency to determine the best path forward to completing the review."


Source: Medindia
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