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BioPharmaceutical

Ovation’s Panhematin Brochure, Monograph Draw FDA Warning Letter

This article was originally published in The Pink Sheet Daily

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Executive Summary

Promotional materials for the porphyria therapy failed to include necessary risk information, including language from a “black box” warning in labeling, the agency says. Ovation says it has submitted a proposed remedial action plan to FDA.
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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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