Report of Foreign Issuer (6-k)
September 08 2016 - 6:04AM
Edgar (US Regulatory)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM 6-K
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REPORT OF FOREIGN PRIVATE ISSUER
Pursuant to Rule 13a-16 or 15d-16
of the Securities Exchange Act of 1934
September 2, 2016
________________
NOVO NORDISK A/S
(Exact name
of Registrant as specified in its charter)
Novo Allé
DK- 2880, Bagsvaerd
Denmark
(Address of principal executive offices)
________________
Indicate by check mark whether the registrant files or will file annual reports under
cover of Form 20-F or Form 40-F
Form 20-F [X]
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Form 40-F [ ]
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Indicate by check mark whether the registrant by furnishing the information contained
in this Form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange
Act of 1934.
If “Yes” is marked, indicate below the file number assigned to the registrant
in connection with Rule 12g-32(b):82-________
FDA extends regulatory review period for IDegLira by
three months
Bagsværd, Denmark, 2 September 2016 -
Novo Nordisk today announced that
the US Food and Drug Administration (FDA) has extended the regulatory review period for IDegLira, the fixed-ratio combination of
insulin degludec and liraglutide in adults with type 2 diabetes.
The FDA informed Novo Nordisk that a three-month extension was required in order to complete
its review of the new drug application (NDA) for IDegLira.
Novo Nordisk submitted the NDA to the FDA in September 2015, and with the extension of
the review the action date is now expected in December 2016.
Further information
Media:
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Katrine Sperling
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+45 3079 6718
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krsp@novonordisk.com
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Ken Inchausti (US)
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+1 609 786 8316
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kiau@novonordisk.com
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Investors:
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Peter Hugreffe Ankersen
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+45 3075 9085
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phak@novonordisk.com
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Melanie Raouzeos
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+45 3075 3479
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mrz@novonordisk.com
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Hanna Ögren
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+45 3079 8519
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haoe@novonordisk.com
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Kasper Veje (US)
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+1 609 235 8567
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kpvj@novonordisk.com
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Novo Nordisk A/S
Investor Relations
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Novo Allé
2880 Bagsværd
Denmark
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Telephone:
+45 4444 8888
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Internet:
www.novonordisk.com
CVR no:
24 25 67 90
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Company announcement No 60 / 2016
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has
duly caused this report to be signed on its behalf of the undersigned, thereunto duly authorized.
Date: September 6, 2016
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NOVO NORDISK A/S
Lars Rebien Sørensen,
Chief Executive Officer
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