Vanda Pharmaceuticals: FDA Rejects Hetlioz Expanded Label

By Colin Kellaher

The U.S. Food and Drug Administration has officially turned away a request from Vanda Pharmaceuticals for expanded approval of its sleep-disorder drug Hetlioz to treat insomnia characterized by difficulties with sleep initiation.

Vanda on Wednesday said the FDA issued a complete response letter, indicating the agency won't approve the application in its current form.

Vanda last month had warned that the FDA, which previously assigned a March 4 target action date for the application, had notified the Washington-based company that it had identified deficiencies that precluded discussion of labeling and post-marketing requirements/commitments.

Vanda on Wednesday said it is reviewing the FDA letter and evaluating its next steps.

The company reported 2023 Hetlioz net product sales of $100.2 million, a 37% decrease from 2022.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

March 06, 2024 07:32 ET (12:32 GMT)

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