Notice of Decision on a Hearing Request Regarding a Proposal To Refuse To Approve a New Dr
The Food and Drug Administration (FDA) is announcing the availability of its decision on a request for a hearing regarding the proposal of FDA's Center for Drug Evaluation and Research (CDER) to refuse to approve a new drug application (NDA) 218489, submitted by Vanda Pharmaceuticals, Inc. (Vanda), for TRADIPITANT caps
| Agency | Health and Human Services Department, Food and Drug Administration |
|---|---|
| Document type | Notice |
| Published | 2026-03-31 |
| Summary | The Food and Drug Administration (FDA) is announcing the availability of its decision on a request for a hearing regarding the proposal of FDA's Center for Drug Evaluation and Research (CDER) to refuse to approve a new drug application (NDA) 218489, submitted by Vanda Pharmaceuticals, Inc. (Vanda), for TRADIPITANT capsules (85 mg) with the proposed indication for "the treatment of [symptoms of] or [nausea in] in gastroparesis" ("symptoms of gastroparesis"). The decision is available in the docket identified by the number in brackets in the heading of this document. |
| Document number | 2026-06187 |
| Official record | https://www.federalregister.gov/documents/2026/03/31/2026-06187/notice-of-decision-on-a-hearing-request-regarding-a-proposal-to-refuse-to-approve-a-new-drug |