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Home » Long Awaited Follow-on Biologic Omnitrope Approved
Long Awaited Follow-on Biologic Omnitrope Approved
June 2, 2006
Sandoz’s generic human growth hormone Omnitrope has finally been approved by the FDA after a nearly three-year delay, making it the first follow-on biologic approved under the 505(b)(2) statute of the Federal Food, Drug and Cosmetic Act (FDCA).