Novo Nordisk receives FDA approval for FlexTouch® in the US
Copenhagen, Denmark, 1 November 2013 – Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved the prefilled insulin pens NovoRapid® FlexTouch® and Levemir® FlexTouch®.
Also, Levemir® FlexTouch® has just been approved by the Canadian health authorities, Health Canada.
FlexTouch® is the latest innovation in prefilled insulin delivery systems from Novo Nordisk. When a dose is dialled with traditional prefilled pens, the push button extends, and at larger doses this can present challenges for the patient1,2. The spring-loaded dosing mechanism of FlexTouch® ensures the push button does not extend at any dose and patients can easily deliver their insulin dose with just a touch of a button1,2.
"Novo Nordisk is committed to continuously developing new and better solutions within insulin delivery, and this approval is an important milestone in the efforts to make the lives of people with diabetes easier", said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk.
NovoRapid® is the most prescribed rapid-acting insulin analogue worldwide3 while Levemir® is a long-acting basal insulin, both have been developed by Novo Nordisk. Novo Nordisk plans to make FlexTouch® available in the US within the next year. FlexTouch® was approved by the European Commission in July 2011 and launched in several countries including the United Kingdom, Denmark and Japan during the last couple of years. NovoRapid® FlexTouch® was launched in Canada in May 2012.
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1. Oyer et al. Expert Opinion on Drug Delivery, 2011;8(10):1259-1269
2. Schipper et al. Current Medical Research & Opinion, 2012;28(8):1297-1303
3. IMS Health Inc. IMS MIDAS, February 2013