FDA Decision to Refuse Approval of Tradipitant Capsules (NDA 218489) for Gastroparesis Treatment

The U.S. Food and Drug Administration (FDA) has issued a final decision to refuse to approve New Drug Application (NDA) 218489, submitted by Vanda Pharmaceuticals, Inc., for Tradipitant capsules at a dose of 85 mg. The proposed indication was for the treatment of symptoms of gastroparesis, a condition that slows or stops the movement of food from the stomach to the small intestine. The decision follows a formal hearing request by Vanda Pharmaceuticals challenging CDER's initial proposal to reject the application. The FDA's Center for Drug Evaluation and Research (CDER) had previously proposed to refuse the NDA, citing unmet evidentiary or regulatory standards. Vanda exercised its right to request a hearing before the agency made its final determination, a procedural mechanism that allows applicants to formally contest a proposed rejection. After conducting the hearing process, FDA has now issued its official decision upholding the refusal to approve. This decision means that Tradipitant capsules will not be permitted for commercial marketing in the United States for the gastroparesis indication at this time. Vanda Pharmaceuticals may pursue further regulatory or legal avenues to challenge the decision or may submit additional data in a future resubmission. The full decision is publicly available in the associated FDA docket.

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