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With respect to the applicant's assertion that TERLIVAZ offers a treatment option for a patient population unresponsive to currently available treatments because among patients in the CONFIRM trial, patients that had failed prior therapy with available options achieved a statistically significant improvement in renal function with TERLIVAZ, we note that the applicant provided evidence from data on file for the clinical study report of the CONFIRM trial

During physical activity or metabolic stress, skeletal muscle generates reactive oxygen species (ROS) as a natural byproduct of mitochondrial respiration and enzymatic reactions

Amount Per Serving: Glutathione 500 mg