Vanda Pharmaceuticals: FDA Identifies Deficiencies In Connection With SNDA For HETLIOZ

(RTTNews) - 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.

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