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(iii) To determine whether the manufacturer of the drug identified as set forth in this paragraph (a)(3) is a first applicant during the 180-day exclusivity period, or whether the manufacturer of this drug is a first approved applicant for a competitive generic drug therapy, CMS will refer to publicly available FDA sources such as the Orange Book and may consult with FDA for technical assistance as needed

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The ongoing fat metabolic breakdown related to IR causes elevated blood circulating FFA levels, which are readily transported to the liver and provide the conditions for fatty liver development [31]