Novo Nordisk resubmits once-weekly semaglutide 2.0 mg for the treatment of type 2 diabetes for US regulatory approval
May 28 2021 - 10:16AM
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 NordiskNovo 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 |
mkd@novonordisk.com |
Michael Bachner
(US) |
+1 609 664
7308 |
mzyb@novonordisk.com |
|
|
|
Investors: |
|
|
Daniel Muusmann
Bohsen |
+45 3075
2175 |
dabo@novonordisk.com |
Valdemar Borum
Svarrer |
+45 3079
0301 |
jvls@novonordisk.com |
Ann Søndermølle
Rendbæk |
+45 3075
2253 |
arnd@novonordisk.com |
David Heiberg
Landsted |
+45
3077 6915 |
dhel@novonordisk.com |
Mark Joseph
Root (US) |
+1 848 213
3219 |
mjhr@novonordisk.com |
Company announcement No 36 / 2021
- PR210528_Sustain_Forte_refiling
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