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FDA warns Novartis about Exelon professional file card

Pharma Compliance Alert, August 22, 2007

In a warning letter posted online last week, DDMAC called for Novartis to stop distributing the professional reference card for Exelon Capsules and Oral Solution because the card makes unsubstantiated superiority claims.

The superiority claim arises from a study comparing Exelon with donepezil, but the FDA judged the study to be inadequate in several respects, including using an open-label design unsuitable for evaluation of a subjective endpoint, a questionable definition of "response," and not including a concurrent control group.

In addition, DDMAC says the card overstates the efficacy of Exelon, includes misleading risk preventions, and recommends or suggests a combination use of Exelon that has not been approved by FDA, creating a new "intended use" for which the PI lacks adequate direction.

The FDA requests Novartis pull the card and circulate new information with correct statements.

Exelon is approved to treat mild to moderate dementia in Alzheimer's disease.

To read the warning letter, click here.

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