Novo Nordisk Resubmits Semaglutide 2.0 Mg For Treatment Of Type 2 Diabetes For US Approval

Danish pharmaceutical company Novo Nordisk A/S (NVO) said Friday that it has resubmitted a label expansion application to the US Food and Drug Administration for the existing marketing authorization for Ozempic or semaglutide, a once-weekly glucagon-like peptide-1 (GLP-1) analogue, to introduce a new dose of 2.0 mg.

The re-submission follows the US Food and Drug Administration issued a Refusal to File letter on 22 March 2021 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 had requested additional information including data relating to a proposed new manufacturing site.

The standard review time by the FDA is 10 months.

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