Warning Letter Sent over Phosphate Binder's Promo Materials

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The FDA posted on its Web site a letter sent to Shire Development, Inc., of Wayne, Pa., regarding promotional materials for its Fosrenol (lanthanum carbonate) chewable tablets for end-stage renal disease.

 

The materials in question were found to have violated the standards for “reminder labeling” marketed to professionals.

 

“The pieces misbrand Fosrenol…as they fail to include, among other things, the drug's product indication as well as material contextual information and information addressing the risks associated with Fosrenol,” said the agency's letter.

 

A Shire spokesman told Medical Marketing & Media that the materials, first introduced at a nephrology conference, were quickly ordered returned to the company.

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