ZOLGENSMA

STN: 125694
Proper Name: onasemnogene abeparvovec-xioi
Trade Name: ZOLGENSMA
Manufacturer: Novartis Gene Therapies, Inc.
Indication:

• For the treatment of pediatric patients less than two years of age with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene.

Product Information

• Package Insert - ZOLGENSMA

Supporting Documents

• June 16, 2026 Approval Letter - ZOLGENSMA
• February 5, 2025 Approval Letter - ZOLGENSMA
• July 26, 2024 Approval Letter - ZOLGENSMA
• October 17, 2023 Approval Letter - ZOLGENSMA
• February 16, 2023 Approval Letter - ZOLGENSMA
• August 5, 2022 Approval Letter - ZOLGENSMA
• October 22, 2021 Approval Letter - ZOLGENSMA
• March 16, 2021 Approval Letter - ZOLGENSMA
• May 24, 2019 Approval Letter - ZOLGENSMA
• May 24, 2019 Summary Basis for Regulatory Action - ZOLGENSMA
• Approval History, Letters, Reviews, and Related Documents - ZOLGENSMA