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Vanda Falls Again As Teva, US FDA Win Judgment In Tasimelteon Approval Case

 
• By Dean Rudge

In its latest legal case, Vanda lost its case against the FDA and Teva over the alleged unlawful approval of the Israeli firm’s generic Hetlioz.

Hand push red Red Cross mark to choose cancellation item , Approve and reject business and document
The court ruled against Vanda in its three challenges of the FDA approval decision. (Shutterstock)
Key Takeaways
  • Vanda Pharmaceuticals lost another legal case against the FDA, this time involving Teva’s generic Hetlioz.
  • A US district court ruled the labeling changes that Teva made with its generic Hetlioz did not violate the same-label requirement.
  • Another case involving Hetlioz against MSN Laboratories is scheduled for trial in June 2026.

A US district court ruled that the US Food and Drug Administration’s approval of Teva’s generic version of Vanda Pharmaceuticals Hetlioz (tasimelteon) was not unlawful, marking another defeat for the...

Teva joined the suit shortly after Vanda filed it against the FDA in 2023 and its cross-motion for summary judgment was granted by the court, which validated the agency’s actions...

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