SIR-Spheres Y-90 resin microspheres
FDA premarket approval P990065/S014 · decided 2025-07-01
Approval details
- PMA number
- P990065
- Supplement
- S014
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SIR-Spheres Y-90 resin microspheres
- Generic name
- Microspheres radionuclide
- Applicant
- Sirtex Medical, Inc.
- Date received
- 2024-01-16
- Decision date
- 2025-07-01
- Days to decision
- 532 days
- Decision code
- APPR
- Product code
- NAW
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Woburn, MA
- Statement
- SIR-Spheres® Y-90 resin microspheres are indicated for the local tumor control of unresectable hepatocellular carcinoma (HCC) in patients with no macrovascular invasion, Child Pugh-A cirrhosis, well-compensated liver function, and good performance status. They are also indicated for the treatment of unresectable metastatic liver tumors from primary colorectal cancer with adjuvant intrahepatic artery chemotherapy (IHAC) of FUDR (Floxuridine).
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