AccretropinTreatment for Pediatric Growth Hormone Deficiency, Turner's Syndrome
Update: Accretropin Now FDA Approved - January 23, 2008
Cangene’s Human Growth Hormone Drug Submission is Accepted for Review by FDA
TORONTO & WINNIPEG, July 17, 2006 -- Cangene today announces that it has filed a regulatory submission (New Drug Application or "NDA") for its recombinant human growth hormone product ("rhGH") with the U.S. Food and Drug Administration ("FDA") and that the submission has been accepted for review. Cangene's rhGH, called 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 United States Federal Food, Drug and Cosmetic Act.
"This is our first recombinant biopharmaceutical to be filed with the FDA and adds to the future potential and diversity of our already strong pipeline, which includes a number of biodefence and infectious-disease-targeted drugs along with the recombinant products," said Dr. John Langstaff, Cangene's president and CEO.
About human growth hormone
Cangene's rhGH is identical in sequence to naturally produced human growth hormone of pituitary origin and is manufactured in the Company's biotechnology manufacturing facility in Winnipeg, Manitoba. 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. A number of approved human growth hormone products made by other companies compete for a large international market.
Turner Syndrome is an X-chromosome-linked genetic disorder in girls that results in short stature and infertility.
Posted: July 2006
- Cangene's Recombinant Human Growth Hormone Accretropin Approved by the U.S. Food and Drug Administration - January 25, 2008
- Cangene Receives an Approvable Letter From the FDA for Human Growth Hormone - March 12, 2007