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Solicitor General Files Brief in Generic Reglan Lawsuit

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Washington, D.C.US Acting Solicitor General Neal Katyal has filed an amicus curiae brief to the Supreme Court arguing that a generic drug manufacturer should not be exempt from warning of its version of Reglan's side effects.

Under current US Food and Drug Administration (FDA) regulations, generic drugs up for agency approval must have the same label as the brand name manufacturer, and the labels must remain consistent with those of their brand name counterparts even after approval has been given.

The issue at stake is whether generic drug manufacturers can add a health warning to their labels that is not present on the labels of the original medication and whether they can be held liable for ensuing adverse side effects.

The manufacturer of the generic version of the gastrointestinal drug Reglan has filed an appeal to the Supreme Court contesting a ruling made by the 8th Circuit Court of Appeals, which decided that the manufacturer was liable for damages because it could have appealed to the FDA for a label change to warn of the health risk, and could have also taken other measures to warn the public and health care professionals of potential side effects.


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