FDA approves first prefilled, multi-dose, disposable growth hormone delivery system for U.S.
PRINCETON, N.J., October 8, 2004 -- Novo Nordisk, the makers of the first insulin delivery system with a pen-like design and the first liquid growth hormone formulation (hGH) available in a pen system, announced that Norditropin NordiFlex (somatropin [rDNA] injection), 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 is a fully integrated delivery system for hGH based on Novo Nordisk's advanced insulin delivery systems. The new disposable Norditropin NordiFlex is prefilled so there is no loading of cartridges.
Fine dosing increments are available in a 5 mg/1.5 mL pen that delivers doses from 0.025 to 1.50 mg, and a 15 mg/1.5 mL pen that delivers doses from 0.075 to 4.5 mg. 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 caregiver and patient to use
- Easy dial-back reset
- Disposable-made of fully degradable plastic
Norditropin cartridges from Novo Nordisk contain growth hormone that has been biosynthetically produced to be as close as possible to the growth hormone your child's body makes naturally. It is virtually identical to natural growth hormone in composition.
Norditropin is indicated for the long-term treatment of children who have growth failure due to inadequate secretion of endogenous growth hormone. Norditropin should not be used in children who are allergic to phenol or any other ingredients in the medicine. Side effects may include headache, muscle pain, weakness, mild hyperglycemia, glucosuria, peripheral edema and fluid retention, and localized reactions at the injection site.
Source: Novo Nordisk www.novonordisk.com
Posted: October 2004