WASHINGTON, March 6,
2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc.
(Vanda) (Nasdaq: VNDA) today announced that on March 4, 2024, it received a Complete Response
Letter (CRL) from the U.S. Food and Drug Administration (FDA) as
part of its ongoing review of Vanda's supplemental New Drug
Application (sNDA) for HETLIOZ® (tasimelteon) in the
treatment of insomnia characterized by difficulties with sleep
initiation.
In July 2023, the FDA had assigned
a Prescription Drug User Fee Act target date of March 4, 2024 for the completion of its review of
the sNDA. As previously reported, on February 4, 2024, the FDA provided a notification
stating that it identified deficiencies that precluded discussion
of labeling and postmarketing requirements/commitments. Consistent
with that notification, the FDA has issued a CRL, indicating that
the FDA cannot approve the sNDA in its present form.
Vanda is reviewing the CRL and evaluating its next steps.
About Vanda Pharmaceuticals Inc.
Vanda is a leading global biopharmaceutical company focused on
the development and commercialization of innovative therapies to
address high unmet medical needs and improve the lives of patients.
For more on Vanda Pharmaceuticals Inc., please visit
www.vandapharma.com and follow us on X @vandapharma.
About HETLIOZ®
For full U.S. Prescribing Information for HETLIOZ®,
including indication and Important Safety Information, visit
www.hetlioz.com.
Corporate Contact:
Kevin Moran
Senior Vice President, Chief Financial Officer and Treasurer
Vanda Pharmaceuticals Inc.
202-734-3400
pr@vandapharma.com
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SOURCE Vanda Pharmaceuticals Inc.