FX.co ★ Vanda Pharmaceuticals Receives CRL From FDA On SNDA For HETLIOZ - Quick Facts

Vanda Pharmaceuticals Inc. recently received a Complete Response Letter from the Food and Drug Administration (FDA). The FDA issued this letter during the ongoing review of a supplemental New Drug Application for HETLIOZ. This drug was developed to treat insomnia, specifically those forms characterized by difficulties initiating sleep. The FDA previously identified certain deficiencies and this most recent letter confirms these issues. It means that, in its current form, the FDA cannot approve the Supplemental New Drug Application. Currently, Vanda Pharmaceuticals is reviewing the details of the letter and deciding on the next steps. To stay informed on health-related news like this, you could visit rttnews.com for more updates.