The FDA’s Office of Orphan Products Development has granted an orphan drug designation for Serono’s Zorbtive™ (Somatropin [rDNA origin] for injection), a recombinant human growth hormone, for use in the treatment of short-bowel syndrome (SBS). SBS is a rare and potentially life-threatening condition that follows extensive surgical removal of portions of the small intestine as [...]
Somatropin (recombinant DNA) injection (Novo Nordisk), a prefilled, multi-dose, liquid growth hormone (Norditropin®) in a disposable pen (NordiFlex®) is now available in the U.S. The medication is indicated for the long-term treatment of children with growth failure resulting from inadequate secretion of endogenous growth hormone and for adults with growth hormone deficiency. esomeprazole 40 mg [...]
Recombinant human growth hormone (hGH) appears to help children with heart failure. Researchers in Boston note that such treatment led to improved left ventricular (LV) mass and function in adults and in animal models. To determine whether the approach would benefit pediatric patients, they studied eight children with stable LV dysfunction attributable to dilated cardiomyopathy. [...]
The FDA has approved a supplemental New Drug Application for somatropin (of rDNA origin for injection) (Genotropin) to treat growth failure associated with Turner syndrome in patients whose bones are still capable of growing. The approval was based on two randomized, open-label, clinical trials in 38 children of short stature with Turner syndrome. Both studies [...]
