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National Organization for Rare Disorders. The FDA approval is supported by results from a multi-center, randomized, open-label, active-controlled Phase 3 study which evaluated the safety and efficacy of NGENLA non-inferiority compared to somatropin, measured by annual height velocity at 12 months. The study met its primary endpoint of NGENLA will be visible as soon as possible as we work to finalize the document.

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