Sandoz has received final FDA approval for its Omnitrope Pen 5 with liquid cartridge.
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Omnitrope, a follow-on biologic, is approved for the long-term treatment of pediatric patients who have growth failure and long-term replacement therapy in adults with growth hormone deficiency. The Omnitrope Pen 5 with liquid cartridge approved by the FDA will be available in 5mg strength in the US shortly.
Bernhard Hampl, CEO of Sandoz, said: “The FDA approval of Omnitrope liquid demonstrates our leadership in follow-on biologics. A year after our initial launch of Omnitrope in the US, we have improved its presentation as part of our continuing our efforts to make it more accessible to patients who need it.”
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