💊FDA Proposes Refusal of TRADIPITANT Drug Application
Proposal to Refuse to Approve a New Drug Application for TRADIPITANT; Opportunity for a Hearing
Summary
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.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The proposed refusal to approve the NDA for TRADIPITANT poses significant regulatory hurdles for Vanda Pharmaceuticals and impacts financial planning. This could necessitate additional trials and delay market entry, affecting revenue projections and investor confidence. Key deadlines require prompt action from the company to address FDA concerns.