Vanda Pharmaceuticals Gets Notice of Opportunity for FDA Meeting

By Josh Beckerman

Vanda Pharmaceuticals Inc. received a notice of opportunity for a Food and Drug Administration hearing on its Supplemental New Drug Application for Hetlioz to treat jet lag disorder.

Hetlioz is currently available for treating Non-24-Hour Sleep-Wake Disorder and nighttime sleep disturbances in Smith-Magenis Syndrome. In 2019, the company received an FDA complete response letter for its sNDA for treating jet lag disorder.

Vanda said Wednesday that it "provided the FDA with four clinical studies that Vanda believes are adequate and well controlled and provide substantial evidence of efficacy." The company said it "does not agree with the FDA's characterization of these studies."

Shares rose 2% to $10.50 after hours.

Write to Josh Beckerman at josh.beckerman@wsj.com

(END) Dow Jones Newswires

September 07, 2022 19:19 ET (23:19 GMT)

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