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The cardiovascular outcomes data are not expected to be available in time for an initial NDA filing, which is consistent with regulatory precedent: the FDA can approve an obesity agent based on weight and safety data, then require post-marketing cardiovascular outcome data as a condition of approval

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While relevance to humans remains uncertain, Zepbound is contraindicated in patients with personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2