Tag Archives: Tresiba

November, 2016

• 22 November

  Novo Nordisk’s Diabetes Drug Xultophy Wins FDA Approval

  

  PLAINSBORO, N.J., Nov. 21, 2016 /PRNewswire/ — Novo Nordisk, a world leader in diabetes care, today announced that the U.S. Food and Drug Administration (FDA) approved the New Drug Application for Xultophy®100/3.6 (insulin degludec 100 units/mL and liraglutide 3.6 mg/mL injection). Xultophy® 100/3.6 is a once-daily, combination of Tresiba® (insulin degludec …

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March, 2015

• 27 March

  Novo Nordisk Announces Plans to Resubmit Rejected Insulin to the FDA

  

  Novo Nordisk A/S announced its decision to resubmit its marketing applications for diabetes drugs Tresiba and Ryzodeg to US health regulators. In 2013, the company submitted marketing applications to the US Food and Drug Administration (FDA) for basal insulin product Tresiba and combination therapy Ryzodeg. Even after an advisory committee …

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