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Pregnant or nursing individuals should avoid glutathione supplements due to insufficient clinical evidence supporting their safety during pregnancy and breastfeeding

In animal models, effects on anxiety- and depression-related behaviors were described, as well as interactions with psychotropic drugs

Jack Khattar, president & CEO of Supernus, said the company remain[s] committed to bringing SPN-830 to the market and will work with the FDA to address the issues identified in the CRL and resubmit the NDA