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Is It Worth The Trouble? The New Policy On Dissemination Of Information On Off-Label Use Under The Food And Drug Administration Modernization Act Of 1997, Elizabeth Weeks Leonard
Is It Worth The Trouble? The New Policy On Dissemination Of Information On Off-Label Use Under The Food And Drug Administration Modernization Act Of 1997, Elizabeth Weeks Leonard
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On January 14, 1998 the Food and Drug Administration (FDA) approved the use of a product previously marketed as Excedrin Extra Strength® for use in treating migraine headaches. As part of the approval for the new use of the product, FDA required the pharmaceutical manufacturer of Excedrin®, Bristol-Myers Squibb, to relabel and repackage the product. The new product is called “Excedrin Migraine®” and is sold side-by-side with Excedrin Extra Strength®. Both over-the-counter (OTC) products contain the same active ingredients: 250 milligrams of acetaminophen, 250 milligrams of aspirin, and sixty-five milligrams of caffeine. Many …