Back to today’s briefing

Story perspectives

Federal Judge Blocks Libervant, Protects Neurelis' Valtoco

2/18/2025

40 5

Summary

Story summary

In a significant legal victory for Neurelis, a federal judge has overturned the FDA's approval of Aquestive Therapeutics' seizure treatment, Libervant. US District Judge Amit P. Mehta determined that the FDA breached the Orphan Drug Act, which safeguards Neurelis' Valtoco, designed for rare conditions, ensuring its exclusivity remains intact.

1 of 1

Story summary

In a significant legal victory for Neurelis, a federal judge has overturned the FDA's approval of Aquestive Therapeutics' seizure treatment, Libervant. US District Judge Amit P. Mehta determined that the FDA breached the Orphan Drug Act, which safeguards Neurelis' Valtoco, designed for rare conditions, ensuring its exclusivity remains intact.