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WASHINGTON - The Food and Drug Administration issued its long-awaited decision on a new human growth product with an approval, but at the same time stressed that this action doesn't set a precedent for other biological medicines.
Approval of Omnitrope, made by Sandoz, was announced Tuesday in a statement on the FDA's Web site.
Omnitrope, also known as somatropin, is a hormone used to treat growth disorders in children and adults.
It is made using recombinant DNA technology, and the approval noted that Omnitrope is considered a follow-on product, meaning it is so similar to other products already approved that the safety and efficacy data for those products could be considered in approving the new version.
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