(RTTNews) - Danish pharmaceutical company Novo Nordisk A/S (NVO) said Monday that the US Food and Drug Administration issued a Refusal to File letter covering the label expansion application for once-weekly semaglutide 2.0 mg for the treatment of type 2 diabetes which was filed on 20 January 2021.
In the letter, FDA has requested additional information including data relating to a proposed new manufacturing site.
Additional information needs to be included in the resubmission. But the company believes the already completed clinical trial program will be sufficient for approval of the label expansion application.
The company expects to resubmit the application to FDA during the second quarter of 2021.
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