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In its Complete Response Letter (CRL), the FDA cited undisclosed product quality and master filing issues for the infusion device, which is proprietary to the device manufacturer, according to Supernus announcement

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Clinical research has demonstrated that GH-deficient adults who restore normal GH levels show significant improvements in lean body mass and exercise capacity (8)

Human clinical trials are scarce, and long-term safety, optimal dosing, and potential side effects remain unclear