11/19/2013

The FDA Office of Prescription Drug Promotion told Daiichi Sankyo that a direct mail piece promoting two versions of hypertension drug Benicar overstates efficacy and asked the company to stop distributing the materials. The promotion claims the drug helped "seven out of ten challenging patients reach goal" in a clinical trial, but the FDA says the referenced study excluded challenging patients.

Full Story:
Regulatory Focus

Related Summaries