WASHINGTON, Sept. 7,
2022 /PRNewswire/ -- Vanda Pharmaceuticals Inc.
(Vanda) (Nasdaq: VNDA) today announced the notice of opportunity
for an FDA hearing on Vanda's Supplemental New Drug Application
(sNDA) for HETLIOZ® (tasimelteon) to treat jet lag
disorder.
On August 19, 2019, Vanda reported
that it had received a Complete Response Letter from the FDA for
Vanda's sNDA for HETLIOZ® for the treatment of jet lag
disorder. On July 1, 2022, Vanda
submitted a request for an opportunity for a hearing under section
505(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355(d)) on the question of whether the sNDA is approvable. On
August 26, 2022, Vanda received a
notice of opportunity for hearing from the FDA. The FDA has
indicated that it will publish the notice in a forthcoming issue of
the Federal Register, but has not indicated when. Vanda is making
the notice available to the public here.
Vanda has provided the FDA with four clinical studies that Vanda
believes are adequate and well controlled and provide substantial
evidence of efficacy for HETLIOZ® in the treatment of
jet lag disorder. Vanda does not agree with the FDA's
characterization of these studies and the conclusions reached by
the FDA with respect to the sufficiency of its evidence to meet the
standard of substantial evidence of efficacy. Vanda welcomes
further administrative proceedings and remains committed to
obtaining FDA marketing approval for HETLIOZ® for the
treatment of jet lag disorder in order to address this significant
unmet medical need.
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 Twitter @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
Elizabeth Van Every
Head of Corporate Affairs
Vanda Pharmaceuticals Inc.
202-734-3400
pr@vandapharma.com
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SOURCE Vanda Pharmaceuticals Inc.