Vanda Pharmaceuticals announced today that it has received a notification from the Food and Drug Administration (FDA) regarding deficiencies in the supplemental new drug application for Hetlioz, an insomnia treatment. These deficiencies prevent the discussion of labeling and postmarketing requirements or commitments at this time.
The FDA's notification is part of the ongoing review process for Hetlioz, specifically for insomnia characterized by difficulties with sleep initiation. It's important to note that the FDA's notification does not reflect a final decision on the information under review, as stated by the FDA.
In a letter dated July 17, 2023, the regulator assigned a Prescription Drug User Fee Act target date of March 4, 2024, for the completion of its review of the supplemental application.
Vanda claims that the timing of the FDA's communication is a violation of the Federal Food Drug and Cosmetic Act (FDCA). According to the FDCA, the FDA is required to either approve a new drug application or provide an opportunity for a hearing within 180 days after the filing of an application. Vanda argues that since it submitted the supplemental application on May 4, 2023, the FDA's deadline under the FDCA was October 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," said Vanda.
Additionally, Vanda is challenging the FDA's approvals of several generic versions of Hetlioz that have been on the market since 2023.