By Robb M. Stewart


Vanda Pharmaceuticals said Monday it has been notified by the Food and Drug Administration of deficiencies in the supplemental new drug application for Hetlioz to treat insomnia that preclude discussion of labeling and postmarketing requirements or commitments.

The notification was part of the ongoing review of Hetlioz for insomnia characterized by difficulties with sleep initiation.

Vanda said no deficiencies were disclosed by the FDA in the notification, and the FDA stated the notification doesn't reflect a final decision on the information under review.

The regulator in a letter dated July 17, 2023, had assigned a Prescription Drug User Fee Act target date of March 4, 2024 for the completion of its review supplemental application.

The biopharmaceutical alleged the timing of the FDA's communication is part of an ongoing violation of the Federal Food Drug and Cosmetic Act , which requires the regulator to either approve a new drug application or provide an opportunity for a hearing within 180 days after the filing of an application. Vanda said that because it submitted the supplemental application on May 4, 2023, the FDA's deadline under the FDCA was Oct. 31. 2023.

"The FDA has not complied with the statute and has not timely approved the application or provided an opportunity for a hearing within the statutorily prescribed timeframe," the company said.

Vanda said it also is challenging the FDA's approvals of several generic versions of Hetlioz that have been marketed since 2023.


Write to Robb M. Stewart at robb.stewart@wsj.com


(END) Dow Jones Newswires

02-05-24 0851ET