Mailer 'Misleads' About Cancer Drug's Efficacy: FDA

Law360, New York (June 23, 2009, 12:00 AM EDT) -- The U.S. Food and Drug Administration told Takeda Pharmaceutical Co. unit Millennium Pharmaceuticals Inc. that a mailer about the billion-dollar cancer drug Velcade was false and misleading because it overstated the drug’s effectiveness.

In a June 18 letter, the FDA requested that Millennium stop disseminating “violative promotional materials” such as the Velcade mailer, which the letter said misbranded Velcade in violation of the Federal Food, Drug and Cosmetic Act and the FDA’s own regulations.

The letter also told Millennium to submit a written response to the...
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