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Zdrowie i gospodarka · 16/01/2025

FDA Director Proposes Refusal of Vanda's TRADIPITANT Drug Application

The FDA Director is proposing to refuse approval of Vanda Pharmaceuticals' new drug application for TRADIPITANT capsules due to concerns over the current formulation, offering Vanda the opportunity to request a hearing.

Source: Federal Register — Food and Drug AdministrationOpen original release →