FDA warns GlaxoSmithKline about Tykerb
Pharma Compliance Alert, December 4, 2007
In a warning letter posted last week, the FDA warned GlaxoSmithKline that three Dear Dr. letters sent out as part of the Tykerb launch campaign are misleading.
According to the FDA, the letters minimize or omit the most serious risk information and overstate the efficacy of Tykerb. Because the materials were used in the launch of the new drug, the letters will help form physicians' first impressions of the drug.
The FDA wants GlaxoSmithKline to stop using the letters immediately. In addition, the FDA asked GlaxoSmithKline to submit a "comprehensive plan of action to disseminate truthful, non-misleading, and complete corrective messages about the issues discussed in this letter to the audience(s) that received the violative promotional materials."
Click here to read the FDA's warning letter.
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