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Novo Nordisk resubmits once-weekly semaglutide 2.0 mg for the treatment of type 2 diabetes for US regulatory approval
Bagsværd, Denmark, 28 May 2021 – Novo Nordisk today announced the resubmission 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. The resubmission follows the Refusal to File letter received by the FDA on 22 March 2021. The standard review time by the FDA is 10 months.
About Novo Nordisk
Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat diabetes and other serious chronic diseases such as obesity and rare blood and endocrine disorders. We do so by pioneering scientific breakthroughs, expanding access to our medicines and working to prevent and ultimately cure disease. Novo Nordisk employs about 45,800 people in 80 countries and markets its products in around 170 countries. Novo Nordisk's B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit novonordisk.com, Facebook, Twitter, LinkedIn, YouTube.
Further information
Media: | ||
Mette Kruse Danielsen | +45 3079 3883 | |
Michael Bachner (US) | +1 609 664 7308 | |
Investors: | ||
Daniel Muusmann Bohsen | +45 3075 2175 | |
Valdemar Borum Svarrer | +45 3079 0301 | |
Ann Søndermølle Rendbæk | +45 3075 2253 | |
David Heiberg Landsted | +45 3077 6915 | |
Mark Joseph Root (US) | +1 848 213 3219 |
Company announcement No 36 / 2021
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