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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 doesnt set a precedent for other biological medicines.
Approval of Omnitrope, made by Sandoz, was announced Tuesday in a statement on the FDAs 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.
The FDAs approval is a breakthrough in our goal of making high-quality and cost-effective follow-on biotechnology medicines like Omnitrope available for health care providers and patients worldwide, Andreas Rummelt, head of Sandoz, said in a statement.
The approval of Omnitrope is a major step forward in bringing needed clarity to the approval process for follow-on biotechnology medicines in the U.S., he said.
However, in its statement the FDA stressed that this action does not establish a pathway for approval of other follow-on products.
The human growth hormone has several characteristics that enable one version to be compared to another for purposes of approval, FDA said. For example, the hormone is well understood, does not have added sugars increasing its complexity and has a long history of clinical use.
Omnitrope has previously been approved for use in Australia and Europe.
Sandoz, a division of Novartis, first applied for approval of the product in July 2003. In 2004 the FDA said it was unable to reach a decision because of scientific and legal issues and it later held public meetings to discuss the approval process for follow-on products.
In 2005 Sandoz filed suit, and on April 10 a federal judge ruled that the FDA must make a decision on the application.
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