4/23/2013 7:36:43 AM
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File this under ‘how could they not know?’ Drugmakers are well aware of the requirements for readying promotional materials, steps that include submitting a form to spell out the messages to be conveyed. Teva Pharmaceuticals, however, was tagged earlier this month by the FDA for preparing a physician handout for its Clozapine schizophrenia medication that was sorely lacking – risks were minimized and various unsubstantiated claims were made. In an April 8 untitled letter, the FDA took the drugmaker to task because the article implied Clozapine demonstrated significant efficacy in treating four of five symptom clusters – excitement, positive, cognitive, and depression/anxiety, as well as specific symptoms of excitement - as well as superiority to other meds.
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