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As used herein, the term "formulation(s)" means any composition(s) containing AD, an alkaline excipient and optionally another excipient(s), that is intended for therapeutic use without further manufacturing

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One more thing worth noting: per the March 3, 2026 FDA press announcement (FDA.gov press announcement, March 3, 2026), the agency targeted companies that made claims implying sameness with FDA-approved products or that obscured the compounded nature of medications

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