Bio-Technology General/DuPont Critical Care growth hormone
Executive Summary
NDA for "authentic" recombinant human growth hormone developed by Bio-Technology General has been filed by marketing partner DuPont. In March FDA granted orphan approval and three years of exclusivity to Lilly's Humatrope as an "authentic" genetically engineered human growth hormone. DuPont is seeking an orphan indication for its human growth hormone product.