FDA Rejects Hearing for Stomach Paralysis Drug Tradipitant
Published Date: 3/31/2026
Notice
Summary
The FDA has decided not to approve Vanda Pharmaceuticals’ new drug, TRADIPITANT capsules, meant to treat symptoms of gastroparesis. Vanda asked for a hearing to challenge this, but the FDA denied it. This means patients and doctors will have to wait longer for this treatment, and Vanda faces delays and extra costs as they figure out their next move.
Analyzed Economic Effects
2 provisions identified: 1 benefits, 1 costs, 0 mixed.
NDA Found Not Approvable as Submitted
On September 18, 2024, the FDA's Office of Immunology and Inflammation issued a complete response letter (CRL) stating that NDA 218489 for TRADIPITANT capsules (85 mg) "could not be approved in its present form." The CRL described specific deficiencies and, where possible, recommended ways Vanda Pharmaceuticals might remedy those deficiencies.
FDA Decision on Hearing Posted to Docket
The FDA issued a decision regarding Vanda's request for a hearing on CDER's proposal to refuse approval of NDA 218489 and submitted that decision to the public docket (Docket No. FDA-2024-N-5933) on March 26, 2026. The decision and related documents are available at Regulations.gov or the Dockets Management Staff in Rockville, MD.
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