Cysview’s Safety Information Not Pretty In Pink, FDA Tells Photocure
This article was originally published in The Pink Sheet Daily
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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Industry also seems supportive of the idea, while Pew touts the power of the power of track-and-trace as a deterrent.
EMD Serono has been tracking Serostim packages since 2002; J&J is using Prezista 600 mg as a trial run for serialization.