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# Novartis Gene Therapy Facility Approved by FDA
- URL: https://www.fdaweb.com/novartis-gene-therapy-facility-approved-by-fda/
- Published: 2022-04-05T12:00:00.000Z
- Updated: 2026-09-14T17:39:28.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151521

FDA has granted commercial licensure approval for a Novartis Durham, NC, multi-product gene therapy manufacturing facility. The company [says](https://www.novartis.com/news/media-releases/novartis-expands-zolgensma-manufacturing-capacity-approval-multi-product-north-carolina-facility?ref=fdaweb.com) the approval allows the state-of-the-art 170,000 square-foot Zolgensma facility to make, test, and release commercial Zolgensma (onasemnogene abeparvovec-xioi), a gene therapy indicated for treating patients under age 2 with spinal muscular atrophy, as well as to produce gene therapy products for current and future clinical trials.

The Durham site joins one in Libertyville, IL, that was approved for Zolgensma manufacturing and distribution in 2019, Novartis says.