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US FDA source recordCRL · Complete Response Letter

NDA 219870 — FDA Complete Response Letter

Issued to Aquestive Therapeutics Inc.. Application reviewed but not approved; deficiencies must be corrected.

Issued

January 30, 2026

Application

NDA 505b1 • 219870

Product

NDA 219870

Company

Aquestive Therapeutics Inc.

Stage

Final Decision

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What did FDA decide for NDA 219870?

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Source facts

FDA's complete response letter contains source-text evidence related to Clinical efficacy and substantial evidence, Device constituent and human factors, Safety and adverse events, Bioequivalence and pharmacokinetics. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.

Key details in this letter

  • 1Clinical efficacy and substantial evidence: 2 source-text matches.
  • 2Device constituent and human factors: 2 source-text matches.
  • 3Safety and adverse events: 1 source-text match.
  • 4Bioequivalence and pharmacokinetics: 1 source-text match.
Clinical efficacy and substantial evidenceDevice constituent and human factorsSafety and adverse eventsBioequivalence and pharmacokineticsLabeling, packaging, and proprietary name

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 219870 complete response letter

What does this complete response letter mean for NDA 219870?

Application reviewed but not approved; deficiencies must be corrected. Requires resubmission addressing deficiencies. FDA issued this letter to Aquestive Therapeutics Inc. on January 30, 2026.

What is NDA 219870?

NDA 219870 is the application under which FDA issued this complete response letter to Aquestive Therapeutics Inc.. The letter is dated January 30, 2026.

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.