FDA warns Protherics for Web page, fact sheet
Pharma Compliance Alert, November 26, 2008
Protherics Inc.’s Web page and fact sheet for its investigational new drug Voraxaze misbrand the product, according to an FDA warning letter.
The FDA said the claims are problematic from a public health standpoint because the FDA has not approved the product and because the promotional claims are not demonstrated by substantial evidence or substantial clinical experience. Both the Web site and the fact sheet make misleading claims about the safety and efficacy of the product and promote its use. Pharmaceutical companies are not permitted to promote a product prior to FDA approval.
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