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Understanding what Form 483 observations mean It is important to provide context about Form 483 findings
According to FDA safety guidelines, the following individuals cannot use tirzepatide: Personal or family history of medullary thyroid carcinoma (MTC) History of neuroendocrine tumors like multiple endocrine neoplasia syndrome type 2 (MEN 2)
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Bydureon [package insert]
Both medications are administered as weekly injections and may cause similar side effects, including nausea or gastrointestinal discomfort
That same 2-unit error at 20 mg/mL costs 0.4 mg
