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US FDA source recordAL · Approval Letter

TRIKAFTA (COPACKAGED) — FDA Approval Letter (NDA 212273)

Issued to VERTEX PHARMS INC. Application is approved as submitted.

Issued

March 19, 2026

Application

NDA 505b1 • 212273

Product

TRIKAFTA (COPACKAGED)

Company

VERTEX PHARMS INC

Stage

Final Decision

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What did FDA decide for TRIKAFTA (COPACKAGED)?

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Source facts

FDA issued an approval letter for TRIKAFTA (COPACKAGED) on 2026-03-19. The source metadata identifies NDA 212273, NDA 217660 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

Key details in this letter

  • 1FDA action: approval.
  • 2Applications: NDA 212273, NDA 217660.
  • 3Submission: supplement.
  • 4Sponsor: VERTEX PHARMS INC.

Suggested next step

Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.

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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 TRIKAFTA (COPACKAGED) approval letter

Is TRIKAFTA (COPACKAGED) FDA approved?

This letter documents an FDA approval action: FDA approved NDA 212273 for TRIKAFTA (COPACKAGED), sponsored by VERTEX PHARMS INC, on March 19, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.

What is NDA 212273?

NDA 212273 is the application under which FDA issued this approval letter for TRIKAFTA (COPACKAGED) to VERTEX PHARMS INC. The letter is dated March 19, 2026.

What happens after an FDA approval letter?

The sponsor may market the product in line with the approved labeling. Approval letters typically set post-approval obligations: submitting final content of labeling, meeting any postmarketing requirements or commitments listed in the letter, updating Orange Book patent information within 30 days for NDAs, and ongoing annual reporting under 21 CFR 314.81.