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Study Supporting Daiichi Sankyo, Inc. (4568.t) Promotional Materials Pummeled By FDA In New Untitled Letter



11/13/2013 7:11:10 AM

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An Untitled Letter sent by the US Food and Drug Administration (FDA) to Daiichi Sankyo regarding promotional materials for two formulations of its hypertension drug Benicar alleges that the materials are misleading and make the drug appear to be more effective than it actually is. The 5 November 2013 letter was sent by FDA's Office of Prescription Drug Promotion (OPDP), and refers to a single advertising piece that co-promotes Benicar (olmersartan medoxomil) and Benicar HCT (olmersartan medoxomil/hydrochlorothiazide) tablets. The drugs are FDA-approved for use in treating hypertension either as monotherapy or as adjuncts with other antihypertensive products.

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