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Regarding FDA approval: because this is a compounded product, it is not directly FDA-approved

Journal of Applied Physiology 110(3):774-780

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As a doctor, theres a lot of burden on your shoulders when you are prescribing something with insufficient evidence, but the patients insist on giving it a try. With no formal approvals surrounding their use from regulatory bodies like the Drugs Controller General of India (DCGI), they are considered off-label treatments