Life Sciences

Shionogi direct mailers misleading, FDA says

Pharma Compliance Alert, November 26, 2008

Shionogi USA Inc.’s Professional NDC Sheet and a Cardinal Health NDC Sheet (direct mailers) for Cedax omit and minimize risks associated with the product, according to an FDA warning letter.

The direct mailers are misleading because they present numerous efficacy claims for Cedax but fail to reveal material risk information associated with use of the drug, and suggest Cedax is effective in a broader range of conditions than has been demonstrated by substantial evidence or substantial clinical experience.

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