Novo nordisk files for regulatory approval in the us of once-weekly semaglutide 2.0 mg for the treatment of type 2 diabetes

BagsvÆrd, denmark, 20 january 2021 – novo nordisk today announced the submission of a label expansion application to the us food and drug administration (fda) for the existing marketing authorisation for ozempic®, a once-weekly glucagon-like peptide-1 (glp-1) analogue, to introduce a new dose of 2.0 mg. ozempic® is currently approved in the us in 0.5 mg and 1.0 mg doses for the treatment of type 2 diabetes in adults and to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease. the submission follows the application on 29 december 2020 for label extension to the european medicines agency (ema).
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