New device approved by FDA for follow-on biologic

PRINCETON, N.J. The Food and Drug Administration has granted approval to Sandoz for its new drug delivery system, Omnitrope Pen 5 with liquid cartridge. The system is used with the first follow-on biologic approved by the FDA, Omnitrope, which was approved in May 2006.

Omnitrope Pen 5 with liquid cartridge is approved to be used for the long-term treatment of pediatric patients who have growth failure and long-term replacement therapy in adults with growth hormone deficiency.

A frozen dry powder version of Omnitrope was launched in the U.S. by Sandoz last January. The new device will be available in a 5 mg strength and will be marketed very soon.

“This FDA approval is another milestone in our continuing efforts to supply healthcare providers and patients with access to high-quality biologic medicines at more affordable prices, an ever-present need in the marketplace,” said Bernard Hampl, chief executive officer of Sandoz.