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

February 5, 2013

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        NOVO NORDISK A/S        
(Exact name of Registrant as specified in its charter)

Novo Allé
DK- 2880, Bagsvaerd
Denmark
(Address of principal executive offices)

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Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F

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-_____________________

 

 

Previously announced FDA Warning Letter published

Bagsværd, Denmark, 5 February 2013 –  Novo Nordisk today announced that the US Food and Drug Administration (FDA) has published the Warning Letter, which the company mentioned in its Financial Statement for 2012 on 31 January.

The Warning Letter is related to a current Good Manufacturing Practice (cGMP) inspection of a filling plant in Bagsværd, Denmark. The company submitted its response to the Warning Letter on 28 December 2012.

Novo Nordisk does not expect the letter to have an impact on products currently marketed in the US.

The letter has been published on FDA’s website:

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm#recent

Novo Nordisk is a global healthcare company with 90 years of innovation and leadership in diabetes care. The company also has leading positions within haemophilia care, growth hormone therapy and hormone replacement therapy. Headquartered in Denmark, Novo Nordisk employs approximately 35,000 employees in 75 countries, and markets its products in more than 180 countries. Novo Nordisk’s B shares are listed on NASDAQ OMX Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit novonordisk.com. 

 

 

 

 

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.