The D.C. Circuit Court of Appeals is poised to make a decision regarding the U.S. Food and Drug Administration’s (FDA) classification of a competing narcolepsy treatment. The issue at hand is whether the FDA erred in its determination that the drug in question should not be considered the “same drug” as a treatment offered by Jazz Pharmaceuticals Inc. During the proceedings, the panel showed considerable skepticism towards the arguments presented by Jazz Pharmaceuticals. This case could have significant implications for how drug equivalency is interpreted in future regulatory decisions.
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