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A competitor cannot file a 351(k) application if it cannot determine what scientific standard it must meet to achieve approval

Robertson AGN et al

Endocrinology 140: 53565363, 1999

Visceral fat releases inflammatory substances and hormones into your bloodstream, contributing to inflammation and insulin resistance

doi: 10.4111/kju.2013.54.11.721

By 2006, manufacturer Amylin earned around $430 million, with sales jumping nearly 50% the following year
