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Clinical trials found no associated increase in arrhythmias or adverse cardiovascular events
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FDA approval timeline FDA designations: Breakthrough Therapy, Priority Review Financial forecast (reported in millions) copper histidinate (CUTX-101) SC Manufacturer: Fortress / Zydus Proposed indications Menkes disease Clinical overview Mechanism of action CUTX-101 is a copper replacement therapy to maintain serum copper levels
Serious risks include systemic infections in immunocompromised patients, and the FDA advises against use in critically ill patients and preterm infants due to potential harm
The higher levels of pigmentation can then cause dark or brown patches on the lips
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