Federal Register #FDA-2024-N-5933

FDA Refusal of Approval for TRADIPITANT Capsules by Vanda Pharmaceuticals

This notice provides an update on the FDA's regulatory decision process regarding a new drug application: - Government Buyer: - Food and Drug Administration (FDA), under the Department of Health and Human Services - Center for Drug Evaluation and Research (CDER) involved in the decision - OEM Mentioned: - Vanda Pharmaceuticals, Inc. (applicant for the drug) - Product Details: - TRADIPITANT capsules (85 mg) - Intended use: Treatment of symptoms or nausea in gastroparesis - NDA number: 218489 - Key Details: - FDA issued a complete response letter and a notice of opportunity for a hearing - Vanda Pharmaceuticals submitted responses and requested a hearing - FDA's final decision is to refuse approval of the application - All related documents are available in the public docket - No procurement of products or services is requested in this notice - No purchase quantities, part numbers, or service requirements are specified

Description

The Food and Drug Administration (FDA) announces its decision on a hearing request concerning the proposal by FDA's Center for Drug Evaluation and Research (CDER) to refuse approval of new drug application (NDA) 218489 submitted by Vanda Pharmaceuticals, Inc. for TRADIPITANT capsules (85 mg) intended to treat symptoms or nausea in gastroparesis. The decision follows a series of regulatory actions including a complete response letter and a notice of opportunity for a hearing. The FDA's final decision and related documents are available in the public docket.

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