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Cysview’s Safety Information Not Pretty In Pink, FDA Tells Photocure

This article was originally published in The Pink Sheet Daily

Executive Summary

Discussing a “pinkish tinge to the urine,” rather than blood, overplays the drug’s safety, the agency says in an advertising letter; also, the patient guide further confounds the safety presentation by first mentioning a common adverse reaction to the imaging drug as an uncommon post-marketing event, FDA says.

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