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US FDA source recordAL · Approval Letter

HERCEPTIN / HERCEPTIN HYLECTA — FDA Approval Letter (BLA 103792)

Issued to GENENTECH. Application is approved as submitted.

Issued

May 19, 2026

Application

BLA • 103792

Product

HERCEPTIN / HERCEPTIN HYLECTA

Company

GENENTECH

Stage

Final Decision

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What did FDA decide for HERCEPTIN / HERCEPTIN HYLECTA?

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Source facts

FDA issued an approval letter for HERCEPTIN, HERCEPTIN HYLECTA on 2026-05-19. The source metadata identifies BLA 103792, BLA 761106 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

Key details in this letter

  • 1FDA action: approval.
  • 2Applications: BLA 103792, BLA 761106.
  • 3Submission: supplement.
  • 4Sponsor: GENENTECH.

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 HERCEPTIN / HERCEPTIN HYLECTA approval letter

Is HERCEPTIN / HERCEPTIN HYLECTA FDA approved?

This letter documents an FDA approval action: FDA approved BLA 103792 for HERCEPTIN / HERCEPTIN HYLECTA, sponsored by GENENTECH, on May 19, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.

What is BLA 103792?

BLA 103792 is the application under which FDA issued this approval letter for HERCEPTIN / HERCEPTIN HYLECTA to GENENTECH. The letter is dated May 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.