Executive Summary

BI disseminated promotional information for Micardis (telmisartan) prior to submitting the materials to FDA for approval, in violation of post-marketing requirements, FDA says in an April 16 letter. In addition, several of the materials that were submitted late include misleading representations of the angiotesin II receptor blocker's efficacy and safety, the letter notes. Use of the header "the time is right for an ARB like Micardis" over safety and efficacy information "implies that other available [ARBs] do not possess similar characteristics, and that Micardis therapy is superior, when compared to them," FDA says. The agency also notes "misleading use of pharmacokinetic data" in BI's presentation of the claim "24-hour half-life for once-daily dosing," which, the agency says, "implies that the duration of clinical effectiveness is due to Micardis' half-life duration"