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Vanda Puts Dog Studies In Spotlight In Suit Challenging FDA Clinical Hold

Executive Summary

Vanda seeks court order requiring US FDA to lift partial clinical hold on its gastroparesis treatment tradipitant; calls on drug makers to oppose agency's animal research policy, saying it requires unjustified killing of dogs.

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Vanda CEO tells the Pink Sheet that the firm is going straight to appellate court to refute agency’s rejection of jet lag indication for Hetlioz. Similar battles may lie ahead over Vanda’s applications on Hetlioz for insomnia and tradipitant for gastroparesis.

Vanda Launches Barrage Of Suits Against FDA Seeking To Retain Hetlioz Market

In 17 suits against FDA in the last two years, firm seeks to block generics of its sleep-wake disorder drug and gain a jet lag indication. CEO Mihael Polymeropoulos tells the Pink Sheet that FDA has retaliated against Vanda for its first suit challenging a partial clinical hold on another drug.

Vanda Is 1-1 In Fights With FDA As Court Grants Its FOIA Request For Review Documents

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