Vanda Pharmaceuticals Inc. (VNDA) said, on February 4, it received a notification from the FDA stating that as part of its ongoing review of Vanda's sNDA for HETLIOZ in the treatment of insomnia characterized by difficulties with sleep initiation, the FDA has identified deficiencies that preclude discussion of labeling and postmarketing requirements/commitments.
In a letter to Vanda dated July 17, 2023, the FDA had assigned a PDUFA target date of March 4, 2024 for the completion of its review of the sNDA. The company said FDA has not provided an opportunity for a hearing within the statutorily prescribed timeframe.
For More Such Health News, visit rttnews.com.
For comments and feedback contact: editorial@rttnews.com
Business News
May 22, 2026 14:46 ET Minutes of the latest Fed policy session was the highlight of the week along with survey data on the U.S. housing market. In Europe, survey data signaled the trends in the euro area private sector. Further, consumer price inflation data from the U.K. was in focus. In Asia, various economic indicators from China drew attention to the health of the economy.