Vanda Pharmaceuticals Inc. disclosed that it has received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) regarding its supplemental New Drug Application (sNDA) for HETLIOZ® (tasimelteon), intended for the treatment of insomnia marked by difficulties with sleep initiation.

The FDA, in its ongoing review, issued the CRL on March 4, 2024, within the timeframe of the Prescription Drug User Fee Act target date set for March 4, 2024. This comes after a notification from the FDA on February 4, 2024, indicating identified deficiencies that hindered discussions on labeling and postmarketing requirements/commitments.

The issuance of the CRL signifies that the FDA cannot approve the sNDA in its current form, as confirmed by Vanda. The company is currently scrutinizing the contents of the CRL and strategizing its next course of action.