FDA warns Cephalon about Treanda dosing information

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The US Food and Drug Administration has sent a warning letter to Cephalon regarding the marketing and promotional material that accompanies its leukemia and lymphoma drug Treanda. In the letter, the FDA claims that Cephalon is disseminating "violative promotional materials", specifically in the dosing card (a handy little card featuring script information used by doctors) that is included with the drug.

According to the letter, Cephalon omits risk information on the dosing card by including "an extremely limited risk presentation", and the company also omits material facts because it "fails to communicate the potential need for dose delays, modifications, reinitiation and discontinuation of therapy for both hematologic and non-hematologic toxicities" of Treanda.

On receipt of the letter, Cephalon withdrew the dosing card.

By Ross Bonander

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