Actavis Hypertension Combo Prompts Discussion Of “Me-Too” Drug Standards
FDA’s Cardiovascular and Renal Drugs Advisory Committee used much of its review of a nebivolol/valsartan combo pill to discuss how much of an improvement a “me-too” product should offer over predecessors and a minimum clinical benefit threshold for antihypertensives.
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Advisory committee members say they’d feel better about approving combo products for hypertension if labeling included pivotal trial data enabling clinicians to assess how individual patients fared on therapy.
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