Sandoz, the generic drugs subsidiary of Swiss drugmaker Novartis, has reported that the U.S. FDA has approved the company's recombinant human growth hormone Omnitrope. Omnitrope was approved using the so-called 505(b)(2) pathway of the Hatch-Waxman Act, becoming the first recombinant copy of a biotech drug to be approved in this manner. The drug is indicated for treatment of growth disorders in children and adults.
"The FDA's 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," said Andreas Rummelt, CEO of Sandoz. "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."
The FDA's decision follows the approval of Omnitrope on April 19 by the European Commission. Omnitrope is now on the market in Germany, with launches planned for additional countries in Europe later this year. The drug is also available in Australia, where it was launched in November 2005.