Regulatory Compliance, Industry Impact
16 Jan 2025
pharmaceuticals, new drug application, fda, drug approval, vanda pharmaceuticals, regulatory compliance
💊FDA Proposes Refusal of TRADIPITANT Drug Application
The Director of the Center for Drug Evaluation and Research (Center Director) at the Food and Drug Administration (FDA or Agency) is proposing to refuse to approve a new drug application (NDA) submitted by Vanda Pharmaceuticals, Inc. (Vanda), for TRADIPITANT capsules, 85 milligrams (mg), in its present form. This notice summarizes the grounds for the Center Director's proposal and offers Vanda an opportunity to request a hearing on the matter.
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