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Drug Review Profile Drug Review Approvals

Giapreza Reviewers

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Executive Summary

US FDA staff who participated in the review and approval of La Jolla Pharmaceutical's distributive shock treatment.

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Lutathera Clinical Development Timeline

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After publication of ATHOS-3 study results, agency received several requests from medical community for emergency use in hospitalized patients with shock and hypotension unresponsive to available therapy, spurring FDA to take an approval action two months ahead of user fee goal date.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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