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.
Other news from the department research and development

Get the life science industry in your inbox
By submitting this form you agree that LUMITOS AG will send you the newsletter(s) selected above by email. Your data will not be passed on to third parties. Your data will be stored and processed in accordance with our data protection regulations. LUMITOS may contact you by email for the purpose of advertising or market and opinion surveys. You can revoke your consent at any time without giving reasons to LUMITOS AG, Ernst-Augustin-Str. 2, 12489 Berlin, Germany or by e-mail at revoke@lumitos.com with effect for the future. In addition, each email contains a link to unsubscribe from the corresponding newsletter.