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Vanda Falls Again As Teva, FDA Win Judgment In ‘Unlawful’ Tasimelteon Approval Case

Originator Argued That Teva’s Hetlioz ANDA Improper Due To Braille Omission On Label

 
• By Dean Rudge

A month after Vanda failed to win a trade secrets case against the US FDA corresponding to generic approvals for its brands Hetlioz and Fanapt, the originator has again fallen, this time to the agency and Teva in the alleged unlawful approval of the Israeli firm’s generic Hetlioz product.

Hand push red Red Cross mark to choose cancellation item , Approve and reject business and document
(Shutterstock)

A US district court in Washington D.C. has ruled in favor of Teva in Vanda Pharmaceuticals’ bid for summary judgment arguing that the US Food and Drug Administration’s approval of Teva’s generic version of the originator’s Hetlioz (tasimelteon) was unlawful, marking another defeat for serial litigator Vanda.

Having joined the suit shortly after it was filed by Vanda against the FDA in 2023, Teva has seen its cross-motion for summary judgment granted by the court. The Israeli...

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