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U.S. FDA approves prefilled, multidose, disposable growth hormone delivery system

Published in Medical Letter on the CDC and FDA, November 14th, 2004

Novo Nordisk, the makers of an insulin-delivery system with a pen-like design and, according to the company, the first liquid-growth-hormone formulation (hGH) available in a pen system, announced that Norditropin NordiFlex (somatropin [rDNA] injection), a premixed, prefilled, multidose, disposable hGH pen, has received FDA (U.S. Food and Drug Administration) 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...

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