Novo Nordisk receives Refusal to File letter for once-weekly semaglutide 2.0 mg for the treatment of type 2 diabetes
March 22 2021 - 5:45PM
Novo Nordisk receives Refusal to File letter for once-weekly
semaglutide 2.0 mg for the treatment of type 2 diabetes
Bagsværd, Denmark, 22 March 2021 – Novo Nordisk
today announced that the US Food and Drug Administration (FDA) has
issued a Refusal to File letter 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. A refusal to
file letter is received when the FDA determines additional
information is required to review a complete application.
In the letter, FDA has requested additional information
including data relating to a proposed new manufacturing
site. While additional information needs to be included in the
resubmission, Novo Nordisk believes the already completed clinical
trial programme will be sufficient for approval of the label
expansion application.
Novo Nordisk expects to resubmit the application to FDA during
the second quarter of 2021.
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
45,000 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 |
Ann Søndermølle
Rendbæk |
+45 3075 2253 |
arnd@novonordisk.com |
Mark Joseph
Root |
+45 3079 4211 |
mjhr@novonordisk.com |
Kristoffer Due
Berg (US) |
+1 609 235
2989 |
krdb@novonordisk.com |
Company announcement No 20 / 2021
- PR210322_SUSTAIN_Forte_refusal_to_file
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