Vanda Pharmaceuticals: FDA grants hearing to review sNDA for Hetlioz

Vanda Pharmaceuticals (VNDA) announced that the U.S. FDA has granted the company’s request for a formal evidentiary public hearing to review the Center for Drug Evaluation and Research’s proposal to refuse approval of Vanda’s supplemental new drug application for Hetlioz in the treatment of jet lag disorder. The FDA confirmed the decision to grant a hearing in a letter from the Office of the Commissioner dated March 2, 2026. The hearing will proceed under 21 CFR Part 12, after which the presiding officer will issue an initial decision pursuant to 21 CFR Section 12.120. Granting a formal evidentiary public hearing in response to a proposed refusal to approve a drug application is a rare and highly significant regulatory step. Publicly available records and historical accounts indicate that the FDA has not granted such a hearing under 21 CFR Part 12 in the context of drug approvals for decades-potentially over 40 years-underscoring the gravity of the legal and scientific issues raised by Vanda.