Life Sciences

Actelion receives FDA warning letter for flash card

Pharma Compliance Alert, December 3, 2008

A flash card for Actelion’s Tracleer tablets presents unsubstantiated superiority claims and omits some of the most important risk information, according to an FDA warning letter.

The FDA said the flash card suggests Tracleer is safer and more effective than has been proven.

The FDA has previously warned Actelion about its promotion for Tracleer. On October 30, 2002, the FDA cited Actelion for false or misleading oral representations made about the use of Tracleer in congestive heart failure, and the failure to disclose any information regarding the risks associated with Tracleer.

On July 20, 2005, the FDA cited Actelion for its false or misleading product page for Tracleer. The product page omitted important risk information, overstated the efficacy of Tracleer, made unsubstantiated superiority claims, and contained claims that broadened the indication for Tracleer.


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