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Novo Nordisk's high-dose semaglutide treatment application for diabetes is rejected by the FDA

 Last Update: 2021-03-26
 Source: Internet
 Author: User

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agr application

diabetes 2 medications

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On March 22, Novo Nordisk issued an announcement stating that the company had received a notification of rejection (RFL) from the US FDA concerning semaglutide 2.

In this RFL, the FDA requested more information, including data related to the proposed new production site.

On January 20 this year, Novo Nordisk submitted a label extension application to the FDA to include a new dose of 2.

The label extension application for semaglutide 2.

The results showed that the study reached the primary endpoint: at the 40th week of treatment, using two evaluation methods, compared with the 1.

The SUSTAIN clinical project is evaluating weekly subcutaneous injections of semaglutide.

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