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PEMIGATINIB — FDA Tentative Approval Letter (ANDA 219552)

Issued to SANDOZ INC. Application meets requirements but marketing is blocked (patent/exclusivity).

Issued

July 21, 2026

Application

ANDA 505j • 219552

Product

PEMIGATINIB

Company

SANDOZ INC

Stage

Final Decision

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What did FDA decide for PEMIGATINIB?

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Source facts

FDA issued a tentative approval letter for PEMIGATINIB on 2026-07-21. The source metadata identifies ANDA 219552 as an original application. Review the exact FDA letter for the approved conditions and labeling.

Key details in this letter

  • 1FDA action: tentative approval.
  • 2Application: ANDA 219552.
  • 3Submission: original application.
  • 4Sponsor: SANDOZ INC.

Suggested next step

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

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FDAPDFUpdated Jul 30, 2026

FDA source document

Read the full FDA tentative approval letter (PDF)

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Common questions about the PEMIGATINIB tentative approval letter

Is PEMIGATINIB FDA approved?

Not for marketing yet. FDA granted tentative approval to ANDA 219552 for PEMIGATINIB on July 21, 2026, meaning the application meets approval standards but patent or exclusivity protections block final approval. The product cannot be marketed until those conditions resolve and FDA issues final approval.

What is ANDA 219552?

ANDA 219552 is the application under which FDA issued this tentative approval letter for PEMIGATINIB to SANDOZ INC. The letter is dated July 21, 2026.

What happens after an FDA tentative approval letter?

The product cannot be marketed yet. Tentative approval means the application meets FDA approval standards, but patent or exclusivity protections block final approval. The sponsor typically requests final approval as the blocking date approaches, and FDA re-verifies that the approval conditions still hold before granting it.