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FDA SENDS WARNING LETTER TO ASTELLAS FOR MISLEADING AD

Sept. 18, 2006

Astellas Pharma US made "unsubstantiated" claims about its anti-rejection drug Prograf and minimized its risks when it placed an ad in a professional journal, the FDA said in a warning letter to the company.

The warning letter, which was dated Aug. 31 and posted to the FDA website Sept. 5, said the company had claimed in the ad that Prograf (tacrolimus capsules and injection), is superior to cyclosporine in that it promotes "stable renal function" and a "favorable cardiovascular profile." These claims, however, are not backed up with substantial evidence or clinical experience, the letter said.

The claim about the favorable cardiovascular profile "misleadingly minimizes the cardiovascular risks associated with Prograf therapy," and the one about stable renal function "misleadingly minimizes the nephrotoxicity associated with Prograf therapy," the warning letter added.

Moreover, two headlines within the ad, "Pro-Grafted for Long Term Success" and "Superior Rejection Prevention" are unacceptable because when taken together they conflict with the drug's approved labeling, the FDA said.

The agency also took issue with the placements and display of the ad's material. "We note that effectiveness claims are presented using large, bolded headers and with a significant amount of white space around them. However, the risk information is presented in the bottom half of the ad in a difficult-to-read font and typography." The letter concluded by asking Astellas Pharma to stop running the ad.

Maribeth Landwehr, the company's assistant director of corporate communications, said that "Astellas is working closely with the FDA to resolve the concerns they raised in their letter."

The warning letter can be accessed at www.fda.gov/cder/warn/2006/Prograf_wl.pdf (http://www.fda.gov/cder/warn/2006/Prograf_wl.pdf).