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 …
Tag Archives: Tresiba
November, 2016
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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 …