FDA TO REVIEW CANGENE'S GROWTH HORMONE DRUG
Cangene has filed a new drug application (NDA) for its recombinant human growth hormone product (rhGH) with the FDA and that the submission has been accepted for review. The company's rhGH, Accretropin, was tested for its ability to combat short stature in children with growth hormone deficiency and girls with Turner syndrome. Cangene submitted this NDA under section 505(b) under the Federal Food, Drug and Cosmetic Act.
Accretropin is identical in sequence to naturally produced human growth hormone of pituitary origin. It is the second product in Cangene's recombinant biopharmaceutical pipeline. Natural human growth hormone is a protein produced by the pituitary gland that acts on the long bones of the body until the onset of puberty and promotes growth to normal stature. A deficiency of this hormone during childhood results in abnormally small stature.