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US FDA source recordCRL · Complete Response Letter

NDA 210862 — FDA Complete Response Letter

Issued to Biohaven Therapeutics, Ltd.. Application reviewed but not approved; deficiencies must be corrected.

Issued

November 4, 2025

Application

NDA 505b1 • 210862

Product

NDA 210862

Company

Biohaven Therapeutics, Ltd.

Stage

Final Decision

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What did FDA decide for NDA 210862?

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Source facts

FDA's complete response letter contains source-text evidence related to Statistical analysis, Clinical efficacy and substantial evidence, Labeling, packaging, and proprietary name, Safety and adverse events. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.

Key details in this letter

  • 1Statistical analysis: 20 source-text matches.
  • 2Clinical efficacy and substantial evidence: 19 source-text matches.
  • 3Labeling, packaging, and proprietary name: 13 source-text matches.
  • 4Safety and adverse events: 2 source-text matches.
Statistical analysisClinical efficacy and substantial evidenceLabeling, packaging, and proprietary nameSafety and adverse eventsNonclinical evidence

Suggested next step

Review the exact redacted FDA letter and address each stated deficiency before resubmission.

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Built from structured FDA metadata and deterministic source-text signals. Topic matches are navigation aids, not legal or regulatory conclusions. Verify material decisions against the original FDA document.

FDAPDFUpdated Jul 30, 2026

FDA source document

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Common questions about the NDA 210862 complete response letter

What does this complete response letter mean for NDA 210862?

Application reviewed but not approved; deficiencies must be corrected. Requires resubmission addressing deficiencies. FDA issued this letter to Biohaven Therapeutics, Ltd. on November 4, 2025.

What is NDA 210862?

NDA 210862 is the application under which FDA issued this complete response letter to Biohaven Therapeutics, Ltd.. The letter is dated November 4, 2025.

What happens after an FDA complete response letter?

FDA will not approve the application in its present form. The sponsor can resubmit after addressing every deficiency listed in the letter — which starts a Class 1 (two-month) or Class 2 (six-month) resubmission review clock — withdraw the application, or request an opportunity for a hearing.