DC Circuit tightens US FDA test for retaining Hatch-Waxman exclusivity
By Nick Robertson ( August 31, 2026, 21:40 GMT | Comment) -- The US Court of Appeals for the DC Circuit found last week that the Food and Drug Administration applied the wrong causation standard when considering forfeiture of the 180-day exclusivity period for the first generic applicant after failing to obtain timely tentative approval. The stricter standard could lead to more exclusivity forfeitures under the Hatch-Waxman Act, attorneys told MLex.The US Court of Appeals for the DC Circuit, in a decision last week, tightened the standard the Food and Drug Administration must apply when determining whether a first generic applicant forfeited its 180-day marketing exclusivity period under its Abbreviated New Drug Application, or ANDA, after failing to obtain tentative approval within 30 months....
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