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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Business News
May 15, 2026 15:25 ET Apart from the confirmation of Kevin Warsh as the next Fed chair, the main news on the economics front this week included key price data from the U.S. and the first quarter economic growth figures from major economies. Both consumer prices and producer costs have started to reflect the effect of supply shocks due to the Middle East conflict. In Europe, GDP data was in focus, while inflation data from China dominated the news flow in Asia.