🚫FDA Denies Vanda's New Drug Application for HETLIOZ Insomnia Treatment
Notice of the Denial of a Hearing Request Regarding a Proposal To Refuse To Approve a Supplemental New Drug Application for HETLIOZ (Tasimelteon)
Summary
The Food and Drug Administration (FDA) is announcing the availability of the decision to deny a request for a hearing regarding the proposal of the Center for Drug Evaluation and Research (CDER) to refuse to approve the supplemental new drug application (sNDA) 205677- 012, submitted by Vanda Pharmaceuticals, Inc. (Vanda), for HETLIOZ (tasimelteon) capsules, 20 milligrams (mg), for the treatment of insomnia characterized by difficulties with sleep initiation. The decision, which also refuses approval of sNDA 205677-012, is available in the docket identified by the number in the heading of this document.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$$ - High
The text highlights the FDA's denial of a supplemental new drug application for HETLIOZ by Vanda Pharmaceuticals, impacting the company's ability to market the drug for a new insomnia indication. This regulatory decision has significant financial implications for Vanda and could affect its market reputation and investment potential.