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Palatin/Mallinckrodt Neutrospec Clears FDA; Imaging Agent Available In Mid-August

This article was originally published in The Pink Sheet Daily

Executive Summary

The radiolabeled monoclonal antibody is approved for diagnosing equivocal appendicitis. Palatin expects to initiate a Phase III trial for diagnosing osteomyelitis by the first quarter of 2005.

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FDA requested trade name change to avoid confusion with a currently marketed drug, Palatin says. NeutroSpec is pending at FDA for diagnosis of equivocal appendicitis; Palatin completed all BLA amendments in first quarter of 2004.

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