Vanda Pharmaceuticals (VNDA) Applications for HETLIOZ Accepted by FDA for Priority Review

Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review Vanda's applications for Smith-Magenis Syndrome (SMS). The applications include a Supplemental New Drug Application (sNDA) for HETLIOZ® capsules and a New Drug Application (NDA) for the liquid formulation of HETLIOZ® for the treatment of adults and children, respectively, with Smith-Magenis Syndrome (SMS). The FDA has set December 1, 2020 as the target date for its decision under the Prescription Drug User Fee Act (PDUFA-VI).

"The FDA filing of the HETLIOZ® applications for priority review marks a major milestone and brings us closer to providing a critical therapy to patients with SMS," said Mihael H. Polymeropoulos, M.D., Vanda's President and CEO. Currently, there are no approved treatments for patients with SMS, a rare orphan disorder affecting approximately 15,000 people in the U.S.

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