hypogonadism; kisspeptin10; compounding; fda 503a

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  1. madman

    FDA Evaluation of Kisspeptin-10: Accordingly, we propose not adding kisspeptin-10 to the 503A Bulks List

    I. INTRODUCTION Kisspeptin-10 was nominated for inclusion on the list of bulk drug substances that can be used in compounding under section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act).1 Kisspeptin-10 was evaluated for the treatment of secondary hypogonadism in men.2,3...
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