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# Regulatory Review Determined for Zolgensma
- URL: https://www.fdaweb.com/regulatory-review-determined-for-zolgensma/
- Published: 2021-06-24T12:00:00.000Z
- Updated: 2026-09-14T17:04:46.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5149613

*Federal Register* notice: FDA has determined for patent extension purposes the regulatory review period for Novartis’ Zolgensma (onasemnogene abeparvovec-xioi), indicated for treating pediatric patients with spinal muscular atrophy with bi-allelic mutations in the survival motor neuron 1 gene. The regulatory review period is 2,088 days, which includes 1,852 days that occurred during the testing phase and 236 days during the approval phase. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2021-06-24/pdf/2021-13411.pdf?ref=fdaweb.com).