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news.The FDA has requested additional information from Canada's Cangene for Accretropin, the company's recombinant human growth hormone.
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The drug’s indication is treatment of growth failure in children with growth hormone deficiency and short stature associated with Turner Syndrome. The FDA requested additional support data regarding manufacturing processes. As fulfilling this requirement does not involve further clinical trials, Cangene anticipates being able to respond quickly.
Cangene has three drugs already approved by the FDA, but this is the first of its recombinant products to be filed in the US. Accretropin was developed under a R&D agreement with the Apotex Group, Cangene’s majority shareholder.