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Originator Merck carried it through Phase 2 trials and a Phase 2b hip-fracture study but never filed for approval, so there is no FDA-approved prescription version

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AIDS Res Hum Retroviruses 12:153741 Novaes R, Freire-de-Lima CG, de Albuquerque RC, Affonso-Mitidieri OR, Espindola O, Lima MA, de Andrada Serpa MJ, Echevarria-Lima J (2013) Modulation of glutathione intracellular levels alters the spontaneous proliferation of lymphocyte from HTLV-1 infected patients

It is the only drug containing gamma hydroxybutyrate approved for medical use in the U.S

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