WASHINGTON - Vanda (NASDAQ:VNDA) Pharmaceuticals Inc. (NASDAQ: VNDA) disclosed that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its supplemental New Drug Application (sNDA) for HETLIOZ® (tasimelteon) aimed at treating insomnia with difficulties in sleep initiation.
The FDA's communication, dated March 4, 2024, informs the biopharmaceutical company that the sNDA cannot be approved in its current form. This follows a previous indication from the FDA on February 4, 2024, which highlighted deficiencies that needed to be addressed before any discussion on labeling and postmarketing requirements or commitments could take place.
Vanda Pharmaceuticals , known for developing innovative therapies for unmet medical needs, is currently reviewing the contents of the CRL to determine its future course of action. The FDA had initially set a target date of March 4, 2024, under the Prescription Drug User Fee Act to complete its review of the sNDA.
HETLIOZ® is already an FDA-approved drug for other uses, and the company was seeking to expand its indications to include treatment for a specific type of insomnia. The CRL is a setback for Vanda as it aims to broaden the application of its product.
The information in this article is based on a press release statement from Vanda Pharmaceuticals Inc. The company's next steps will be closely watched by investors and patients alike as it works to address the FDA's concerns and potentially resubmit the sNDA for HETLIOZ®.
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