2013年8月21日讯 /SciFans.net/ --糖尿病护理巨头—诺和诺德(Novo Nordisk)今天宣布,胰岛素笔NovoPen Echo已获FDA批准,这是美国市场上首个也是唯一一个具有半单位剂量和记忆功能的胰岛素笔,能够帮助患者更好地管理自己的糖尿病。
该胰岛素笔是诺和诺德最新的胰岛素递送系统。半单位剂量递增,允许更精细的调整,这对于儿童患者尤其重要。
诺和诺德计划于2014年初在美国推出NovoPen Echo。目前,NovoPen Echo已在欧洲、加拿大、以色列上市。(SciFans.net)
英文原文:Novo Nordisk receives U.S. FDA clearance for the insulin injection device NovoPen Echo?
First insulin injection device to combine half-unit dosing with a memory function to help patients better manage their diabetes
PLAINORO, N.J., Aug. 21, 2013 /PRNewswire/ -- Novo Nordisk, a world leader in diabetes care, announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the insulin device NovoPen Echo?. This marks the first and only pen device in the U.S. with half-unit dosing and a memory function that records the dose and time passed since the last injection.
This pen is the latest insulin delivery system from Novo Nordisk, and will be available to patients for use with NovoLog? (insulin aspart [rDNA origin] injection) PenFill? cartridges.
"The U.S. approval of NovoPen Echo? represents a significant milestone in insulin delivery, especially for children with diabetes and their caregivers," said Camille Lee, senior vice president, Diabetes Marketing at Novo Nordisk. "The pen can offer caregivers increased confidence that their children are managing their diabetes appropriately away from home by allowing them to see the amount and time passed since their last dose."
Half-unit dose increments allow for finer adjustments, which can be particularly important for children. In addition, different removable skins will be available for a kid-friendly customized look.
Novo Nordisk plans to make NovoPen Echo? available in the U.S. in early 2014. NovoPen Echo? has already launched in Europe, Canada, and Israel.