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# FDA Denies Public Citizen Hetlioz Petition
- URL: https://www.fdaweb.com/fda-denies-public-citizen-hetlioz-petition/
- Published: 2020-01-30T12:00:00.000Z
- Updated: 2026-09-14T16:00:39.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145976

FDA has denied a Public Citizen 6/11/15 petition asking the agency to revise the Indications and Usage, Carcinogenesis, Mutagenesis, and Pregnancy sections of the labeling for Vanda’s Hetlioz (tasimelteon) capsules. The petition also asked that once the labeling is changed, FDA require distribution of a Medication Guide, require the sponsor to issue a “Dear Doctor” letter about the narrower indication sought in the petition, and require Vanda to conduct a long-term postmarketing clinical trial.

The agency denial [letter](https://www.regulations.gov/contentStreamer?documentId=FDA-2015-P-2142-0006&attachmentNumber=1&contentType=pdf&ref=fdaweb.com) says FDA continues to believe that the approved indication for treating non-24-hour sleep-wake disorder is appropriate. “We also continue to believe that Hetlioz’ benefits outweigh its risks for its approved indication and that its risks are adequately addressed in the current labeling,” the letter says.

Since FDA sees no need to require labeling changes, the letter says, there is no need for a Medication Guide, “Dear Doctor” letter, or postmarketing safety study.