Cangene's recombinant human growth hormone approved by the U.S. Food and Drug Administration
Cangene announced that the U.S. food and Drug Administration ("FDA") has approved Accretropin(TM) (somatropin (rDNA origin)) Injection, Cangene's recombinant human growth hormone ("rhGH"). The drug is indicated for treatment of pediatric patients who have growth failure due to an inadequate secretion of normal endogenous growth hormone, or treatment of short stature associated with Turner syndrome in pediatric patients whose epiphyses are not closed.
"This is a significant accomplishment. Accretropin(TM) is our first recombinant product approval. Cangene continues to demonstrate that it can take new products from development to approval effectively," said Dr. John Langstaff, president and CEO of Cangene. "We now have four FDA-approved drugs."
Accretropin(TM) was submitted under section 505(b) of the United States Federal Food, Drug and Cosmetic Act in 2006. The product was developed under a research and development agreement with the Apotex Group, Cangene's majority shareholder, and Apotex retains marketing rights for the product. Apotex and Cangene are assessing the current market situation and related patent issues to determine the most effective overall strategy for this product going forward.
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