Sandoz has been granted approval by the FDA for its recombinant human growth hormone Omnitrope as the first follow-on version of a previously approved recombinant biotechnology drug. Omnitrope is indicated for treatment of growth disorders in children and adults. It was approved in the U.S. using the 505(b)(2) pathway of the Hatch-Waxman Act, becoming the first recombinant copy of a biotech drug to be approved by this manner. Omnitrope is considered a generic version of Pfizer’s human grow...