1 – 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.
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 4 5 , 8 00 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 .
|Mette Kruse Danielsen||+45 3079 email@example.com|
|Michael Bachner (US)||+1 609 664 firstname.lastname@example.org|
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Company announcement No 36 / 2021