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Vanda Pharmaceuticals' APA claims against US FDA dismissed, but Appointments Clause challenge survives

( September 10, 2024, 10:10 GMT | Official Statement) -- MLex Summary: A US judge has dismissed allegations the US Food and Drug Administration violated the Administrative Procedure Act when approving MSN Pharmaceuticals' bioequivalent to Vanda Pharmaceuticals' sleep disorder drug Hetlioz. The judge said that a Citizen Petition, also filed by Vanda, should first be ruled on by the FDA. Allegations by Vanda that the FDA runs afoul of the Appointments Clause may have merit, however. The judge gave the agency 60 days to remedy possible constitutional deficiencies with its approval of the MSN bioequivalent.See document below....

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