FDA Puts Sleep Aid Dreams on Hold with Hearing Denial
Published Date: 3/7/2025
Notice
Summary
The FDA said no to Vanda Pharmaceuticals’ request for a hearing about their new drug application for HETLIOZ capsules, which are meant to help people who have trouble falling asleep. This means the FDA won’t approve the new use of HETLIOZ right now. Patients and doctors waiting for this treatment update will have to keep waiting, and Vanda won’t get the green light or any new sales from this application yet.
Analyzed Economic Effects
1 provisions identified: 0 benefits, 1 costs, 0 mixed.
FDA Refuses HETLIOZ Supplemental Approval
The FDA refused to approve Vanda Pharmaceuticals’ supplemental new drug application (sNDA 205677-012) for HETLIOZ (tasimelteon) 20 mg to treat insomnia with difficulty falling asleep. Because the FDA also denied Vanda’s request for a hearing, doctors and patients waiting for this new use must keep waiting and Vanda cannot market or sell HETLIOZ for that use now.
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