Evita Solutions filed its generic mifepristone application in 2021, but the FDA typically processes such applications within 10 months.

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Evita filed its ANDA (Abbreviated New Drug Application) in 2021, and the FDA typically processes generic applications within 10 months. Evita's approval took over three years, suggesting the FDA delayed processing during politically sensitive periods—possibly during the Dobbs litigation or after the Supreme Court decision. The extended timeline reveals how political pressure can slow routine regulatory processes even when agencies lack legal authority to deny applications, creating administrative delays that function as de facto restrictions without formal rejections.

Evita Solutions filed its generic mifepristone application in 2021, but the FDA typically processes such applications within 10 months.

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