FDA Warns Novartis About Misleading Promotional Websites for Cancer Drug

The Food and Drug Administration has warned Novartis Pharmaceuticals Corp. that two promotional websites for Gleevec (imatinib mesylate) are false and misleading, according to a warning letter posted May 4 on FDA’s website.

FDA said the websites are false and misleading because they promote the drug for an unapproved use, fail to disclose the drug’s risks, and make unsubstantiated dosing claims. Additionally, FDA said the information on the websites (www.gistalliance.com and www.cmlalliance.com) was not submitted to the agency before it was published, as required.

Gleevec is indicated for the treatment of certain types of cancer. The drug is associated with ...