Novo Nordisk has announced that Norditropin NordiFlex (somatropin [rDNA] injection), the first premixed, prefilled, multi-dose, disposable hGH pen, has received US 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, the company release says.

"With Norditropin NordiFlex treatment with growth hormone has been made simple, as this product eliminates the need for reconstitution and the complex loading of devices. Novo Nordisk is proud to add to its history of innovation in growth hormone treatment," said Michael Shalmi, vice president of biopharmaceuticals, Novo Nordisk Pharmaceuticals, Inc.

According to company sources, 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.

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, first produced biosynthetic growth hormone in 1985. In 1999, the company introduced a liquid growth hormone formulation that did not require a reconstitution or mixing procedure before injection. This was a major advance in simplifying growth hormone therapy for patients.

Norditropin is indicated for the long-term treatment of children who have growth failure due to inadequate secretion of endogenous growth hormone.