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Page 2 Mr. Fisher DEPARTMENT OF HEALTH HUMAN SERVICES Public Health Service Food and Drug Administration 1401 Rockville Pike Rockville MD 20852-1448 Our STN BL 125398/0 Novo Nordisk Inc. Attention Mr. Robert Fisher 100 College Road West Princeton NJ 08540 Dear Mr. Fisher We have reviewed your amendment dated May 16 2013 to your biologics license application BLA for Coagulation Factor XIII A Subunit Recombinant requesting a change of the proprietary name for Coagulation Factor XIII A Subunit...
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