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Accretropin FDA Approval History

FDA Approved: Yes (Discontinued) (First approved January 23, 2008)
Brand name: Accretropin
Generic name: somatropin (rDNA origin)
Dosage form: Subcutaneous Injection
Company: Emergent
Treatment for: Pediatric Growth Hormone Deficiency, Turner Syndrome

Marketing Status: Discontinued

Accretropin (somatropin (rDNA origin)) is recombinant human growth hormone 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.

Development timeline for Accretropin

Jan 25, 2008Approval Cangene's Recombinant Human Growth Hormone Accretropin Approved by the U.S. Food and Drug Administration
Mar 12, 2007Cangene Receives an Approvable Letter From the FDA for Human Growth Hormone
Jul 17, 2006Cangene’s Human Growth Hormone Drug Submission is Accepted for Review by FDA

Further information

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