Source facts
FDA issued an approval letter for GALLIUM GA 68 GOZETOTIDE on 2026-07-21. The source metadata identifies ANDA 219189 as an original application. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
GALLIUM GA 68 GOZETOTIDE — FDA Approval Letter (ANDA 219189)
Issued to IONETIX. Application is approved as submitted.
Issued
July 21, 2026Application
ANDA 505j • 219189
Product
GALLIUM GA 68 GOZETOTIDE
Company
IONETIX
Stage
Final Decision
Assyro regulatory brief
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Key details in this letter
- 1FDA action: approval.
- 2Application: ANDA 219189.
- 3Submission: original application.
- 4Sponsor: IONETIX.
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Common questions about the GALLIUM GA 68 GOZETOTIDE approval letter
Is GALLIUM GA 68 GOZETOTIDE FDA approved?
This letter documents an FDA approval action: FDA approved ANDA 219189 for GALLIUM GA 68 GOZETOTIDE, sponsored by IONETIX, on July 21, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is ANDA 219189?
ANDA 219189 is the application under which FDA issued this approval letter for GALLIUM GA 68 GOZETOTIDE to IONETIX. The letter is dated July 21, 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.