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.
Your PRIA Score
Personalized for You
How does this regulation affect your finances?
Sign up for a PRIA Policy Scan to see your personalized alignment score for this federal register document and every other regulation we track. We analyze your financial profile against policy provisions to show you exactly what matters to your wallet.
Key Dates
Department and Agencies
Take It Personal
Get Your Personalized Policy View
Start a Free Government Policy Watch to see how policy affects your household, then upgrade to PRIA Full Coverage for year-round monitoring.
Already have an account? Sign in