FDA approves innovative delivery device for hGH
Norditropin NordiFlex, the first premixed, prefilled, multi-dose, disposable hGH pen, has received FDA approval for the long-term treatment of children with growth failure due to inadequate secretion of endogenous growth hormone.
Norditropin NordiFlex, the first premixed, prefilled, multi-dose, disposable hGH pen, has received FDA approval for the long-term treatment of children with growth failure due to inadequate secretion of endogenous growth hormone.
The device is based on Novo Nordisk's advanced insulin delivery systems.
In 1999, Novo Nordisk introduced a new pen system to Europe and Japan to deliver liquid hGH, while using one of the thinnest and finest needles available. The premixed Norditropin cartridge (somatropin [rDNA origin] injection) and NordiPen delivery system were introduced in the US in 2000, and the NordiPenMate auto-insertion device became available in 2001.
Fine dosing increments are available in a 5mg/1.5mL pen that delivers doses from 0.025-1.50mg, and a 15mg/1.5mL pen that delivers doses from 0.075-4.5mg. Between these two delivery systems, a total of 100 different dosing options are available.
Key features of Norditropin NordiFlex include:
• Ease of use: no loading, no mixing (reconstitution)
• Ease of training - for the healthcare professional to teach and the care-giver and patient to use
• Easy dial-back reset
• Disposable: made of fully degradable plastic
'With Norditropin NordiFlex, treatment with growth hormone has been made simple, as it eliminates the need for reconstitution and the complex loading of devices,' said Dr Michael Shalmi, vice president of biopharmaceuticals, Novo Nordisk Pharmaceuticals, Inc. 'Novo Nordisk is proud to add to its history of innovation in growth hormone treatment.'