FDA Denies Vanda Pharmaceuticals' Request for Hearing on HETLIOZ Insomnia Treatment
March 07, 2025
March 07, 2025
WASHINGTON, March 7 (TNSFR) -- The Food and Drug Administration has issued a final decision denying Vanda Pharmaceuticals, Inc.'s request for a hearing regarding its supplemental new drug application for HETLIOZ (tasimelteon) capsules, 20 mg, as a treatment for insomnia characterized by difficulties with sleep initiation.
The decision also formally refuses approval of the application, concluding that the drug lacks substantial evidence of effectiveness for the proposed indicat . . .
The decision also formally refuses approval of the application, concluding that the drug lacks substantial evidence of effectiveness for the proposed indicat . . .