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Importantly, the announcement does not indicate that the peptides will be placed on the Category 1 May Compound list, possibly leaving those bulk drug substances in limbo unless the FDA announces enforcement discretion with regard to the substances

Am J Physiol Endocrinol Metab (2012) 303(2):E26571

Or drop coverage and devastate the employees who depended on it

Recent FDA approvals include palopegteriparatide (Yorvipath) for hypoparathyroidism, levacetylleucine (Aqneursa) for Niemann-Pick disease, pegulicianine (Lumisight) for breast cancer imaging, and elamipretide (Forzinity) for Barth syndrome

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