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# Vanda, FDA Agree to Hetlioz Submissions
- URL: https://www.fdaweb.com/vanda-fda-agree-to-hetlioz-submissions/
- Published: 2020-05-13T12:00:00.000Z
- Updated: 2026-09-14T16:14:41.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146786

Vanda Pharmaceuticals says it has reached agreement with FDA to resubmit an NDA and supplemental NDA for Hetlioz (tasimelteon) for treating Smith-Magenis Syndrome (SMS). In March, Vanda received a refusal to file letter, asking that the company separate its NDA into two submissions — a supplemental NDA for the solid capsule formulation of Hetlioz for treating adults with SMS and a new NDA for a liquid formulation of Hetlioz for treating children.  

In 12/2018, Vanda reported results of what it called the largest placebo controlled study ever conducted in patients with SMS, with Hetlioz patients seeing significant improvements in sleep, the company says. SMS is a developmental disorder that is frequently caused by a small deletion of human chromosome 17p. The most common symptom of SMS is a severe sleep disorder.