Life Sciences

Journal ad for Bystolic misleading

Pharma Compliance Alert, September 10, 2008

Forest Laboratories’ eight-page journal ad for Bystolic claims the drug is safer and more effective than has been demonstrated, according to an FDA warning letter.

The FDA said the drug is misbranded because the ad:
  • Makes unsubstantiated superiority and mechanism of action claims
  • Omits and minimizes risks
  • Makes unsubstantiated efficacy claims

The FDA wants Forest Laboratories to stop using the ad and submit a plan for how it will disseminate truthful, non-misleading, and complete corrective messages.


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