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A comprehensive review of capsaicin: Biosynthesis, industrial productions, processing to applications, and clinical uses

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Challengers received the Abbreviated New Drug Application (ANDA) pathway, which allows a generic to demonstrate bioequivalence to the reference listed drug without repeating the innovators clinical trials, plus a research safe harbor allowing them to conduct development activities during the patent term without infringement liability, and the 180-day exclusivity reward for challenging brand patents via P.IV certification

At the highest dose of 12 mg, participants achieved mean body weight reduction of 16.9% compared to 3.0% with placebo