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Otsuka Pletal

Executive Summary

Safety concerns will be addressed in product labeling adequately, the company says in response to a Dec. 30 Public Citizen's Health Research Group letter to FDA ("The Pink Sheet" Jan. 4, In Brief). Cilostazol labeling will include tables offering guidance on concomitant use with several other cardiovascular-related drugs, the company says, and a physician education initiative will be part of the product launch. The firm says it is also in consultation with FDA to design a long-term safety study expected to last two years. Pletal has been "approvable" as a treatment for intermittent claudication since Sept. 18. The company says it is close to finalizing labeling, the last issue outstanding
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PS033439

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