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DOJ tells US judge not to rush ruling on Vanda's Appointments Clause challenge

( April 23, 2025, 13:14 GMT | Official Statement) -- MLex Summary: In an opposition brief, the US Department of Justice told US Judge Christopher R. Cooper to deny a request for a court order requiring the US Food and Drug Administration to respond to Vanda Pharmaceuticals’ citizen petition by May 31 and its motion to open summary judgment briefing on its constitutional challenge to the FDA’s generics approval process. The September 2023 lawsuit by Vanda, maker of the sleep disorder drug Hetlioz, disputes the form and substance of the FDA’s January 2023 initial approval of an application by MSN Pharmaceuticals to manufacture generic tasimelteon. Cooper previously paused proceedings unofficially in order to give the FDA time to respond to Vanda’s citizen petition, but Vanda on April 8 argued the FDA’s extension of its timeline to do so means the court should reach its challenges now. The FDA said it “merely revised its original estimate by at most one month” and that that delay, alone, “does not justify throwing out the commonsense case-management approach that this Court has repeatedly reaffirmed.”See attached document....

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