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Appointments Clause challenge by Vanda will remain on hold, US judge rules

( May 1, 2025, 18:18 GMT | Official Statement) -- MLex Summary: In a minute order, US Judge Christopher Cooper denied Vanda Pharmaceuticals leave to renew its motion for summary judgment in a legal dispute with the US Food and Drug Administration over the agency’s process for approving generic drug applications. The drugmaker unsuccessfully argued Cooper should reach its challenge under the Appointments Clause, codified at U.S. Const. art. II, § 2, cl. 2., prior to the FDA’s response to Vanda’s related citizen petition. That response — originally pegged for the “spring of 2025” — now is not expected until “late June.” In its September 2023 lawsuit, Vanda says the FDA failed to properly assess the rigor and methodology of studies which purportedly show bioequivalence between MSN Pharmaceuticals’ generic tasimelteon and Vanda’s Hetlioz, a sleep disorder drug featuring tasimelteon as its active ingredient.Docket entry follows....

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