Zolgensma Purple Book BLA 125694

BLA number: 125694
Proprietary names: Zolgensma
Proper names: onasemnogene abeparvovec-xioi
Applicant: Novartis Gene Therapies, Inc.
Center: CBER
First observed release: 2020-08-01
Latest observed release: 2026-06-01
Newest archive release: 2026-06-01
FDA patent list: No patents listed in the captured FDA patent list; source updated 2025-06-11
Coverage: Present in newest release

Latest Known Product Presentations#

Product, Proprietary name, Proper name table
Product	Proprietary name	Proper name	License type	Strength	Dosage form	Route	Presentation	Marketing	Licensure	Approval	Patent list provided
001	Zolgensma	onasemnogene abeparvovec-xioi	351(a)	2x10^13VG/ML	Injection	Intravenous	Single-Dose Vial	Rx	Licensed	2019-05-24

Published Patent List#

No patents for this BLA were listed in the FDA Purple Book patent list captured from the source updated 2025-06-11.

NDC, Proprietary name, Nonproprietary name table
NDC	Proprietary name	Nonproprietary name	Labeler	Source
71894-120	Zolgensma	onasemnogene abeparvovec-xioi	Novartis Gene Therapies, Inc.	current
71894-121	Zolgensma	onasemnogene abeparvovec-xioi	Novartis Gene Therapies, Inc.	current
71894-122	Zolgensma	onasemnogene abeparvovec-xioi	Novartis Gene Therapies, Inc.	current
71894-123	Zolgensma	onasemnogene abeparvovec-xioi	Novartis Gene Therapies, Inc.	current
71894-124	Zolgensma	onasemnogene abeparvovec-xioi	Novartis Gene Therapies, Inc.	current
71894-125	Zolgensma	onasemnogene abeparvovec-xioi	Novartis Gene Therapies, Inc.	current
71894-126	Zolgensma	onasemnogene abeparvovec-xioi	Novartis Gene Therapies, Inc.	current
71894-127	Zolgensma	onasemnogene abeparvovec-xioi	Novartis Gene Therapies, Inc.	current
71894-128	Zolgensma	onasemnogene abeparvovec-xioi	Novartis Gene Therapies, Inc.	current
71894-129	Zolgensma	onasemnogene abeparvovec-xioi	Novartis Gene Therapies, Inc.	current
71894-130	Zolgensma	onasemnogene abeparvovec-xioi	Novartis Gene Therapies, Inc.	current
71894-131	Zolgensma	onasemnogene abeparvovec-xioi	Novartis Gene Therapies, Inc.	current
71894-132	Zolgensma	onasemnogene abeparvovec-xioi	Novartis Gene Therapies, Inc.	current
71894-133	Zolgensma	onasemnogene abeparvovec-xioi	Novartis Gene Therapies, Inc.	current
71894-134	Zolgensma	onasemnogene abeparvovec-xioi	Novartis Gene Therapies, Inc.	current
71894-135	Zolgensma	onasemnogene abeparvovec-xioi	Novartis Gene Therapies, Inc.	current
71894-136	Zolgensma	onasemnogene abeparvovec-xioi	Novartis Gene Therapies, Inc.	current
71894-137	Zolgensma	onasemnogene abeparvovec-xioi	Novartis Gene Therapies, Inc.	current
71894-138	Zolgensma	onasemnogene abeparvovec-xioi	Novartis Gene Therapies, Inc.	current
71894-139	Zolgensma	onasemnogene abeparvovec-xioi	Novartis Gene Therapies, Inc.	current
71894-140	Zolgensma	onasemnogene abeparvovec-xioi	Novartis Gene Therapies, Inc.	current
71894-141	Zolgensma	onasemnogene abeparvovec-xioi	Novartis Gene Therapies, Inc.	current
71894-142	Zolgensma	onasemnogene abeparvovec-xioi	Novartis Gene Therapies, Inc.	current
71894-143	Zolgensma	onasemnogene abeparvovec-xioi	Novartis Gene Therapies, Inc.	current
71894-144	Zolgensma	onasemnogene abeparvovec-xioi	Novartis Gene Therapies, Inc.	current
71894-145	Zolgensma	onasemnogene abeparvovec-xioi	Novartis Gene Therapies, Inc.	current
71894-146	Zolgensma	onasemnogene abeparvovec-xioi	Novartis Gene Therapies, Inc.	current
71894-147	Zolgensma	onasemnogene abeparvovec-xioi	Novartis Gene Therapies, Inc.	current
71894-148	Zolgensma	onasemnogene abeparvovec-xioi	Novartis Gene Therapies, Inc.	current
71894-149	Zolgensma	onasemnogene abeparvovec-xioi	Novartis Gene Therapies, Inc.	current
71894-150	Zolgensma	onasemnogene abeparvovec-xioi	Novartis Gene Therapies, Inc.	current
71894-151	Zolgensma	onasemnogene abeparvovec-xioi	Novartis Gene Therapies, Inc.	current
71894-152	Zolgensma	onasemnogene abeparvovec-xioi	Novartis Gene Therapies, Inc.	current
71894-153	Zolgensma	onasemnogene abeparvovec-xioi	Novartis Gene Therapies, Inc.	current
71894-154	Zolgensma	onasemnogene abeparvovec-xioi	Novartis Gene Therapies, Inc.	current
71894-155	Zolgensma	onasemnogene abeparvovec-xioi	Novartis Gene Therapies, Inc.	current
71894-156	Zolgensma	onasemnogene abeparvovec-xioi	Novartis Gene Therapies, Inc.	current

Label, Manufacturer, Effective table
Label	Manufacturer	Effective
Zolgensma	Novartis Innovative Technologies Inc.	2026-06-16
Zolgensma	Novartis Innovative Technologies Inc.	2026-06-12
Zolgensma	Novartis Gene Therapies, Inc.	2025-12-18

Official Monthly Change Events#

Release, Event, Product table
Release	Event	Product	Name	License type	Status	Applicant
2025-12-01	U	001	Zolgensma	351(a)	Rx	Novartis Gene Therapies, Inc.
2024-07-01	U	001	Zolgensma	351(a)	Rx	Novartis Gene Therapies, Inc.
2022-05-01	U	001	Zolgensma	351(a)	Rx	Novartis Gene Therapies, Inc.
2021-09-01	U	001	Zolgensma	351(a)	Rx	Novartis Gene Therapies, Inc.
2021-05-01	U	001	Zolgensma	351(a)	Rx	Novartis Gene Therapies, Inc.
2020-08-01	R	001	Zolgensma	351(a)	Rx	AveXis, Inc.

Observed Product State History#

Release, Product, Name table
Release	Product	Name	License type	Marketing	Licensure	Approval
2022-05-01	001	Zolgensma	351(a)	Rx	Licensed	2019-05-24
2020-08-01	001	Zolgensma	351(a)	Rx	Licensed	2019-05-24

Zolgensma Purple Book BLA 125694

Related Records#

Latest Known Product Presentations#

Published Patent List#

Related NDC Products#

Related DailyMed Labels#

Official Monthly Change Events#

Observed Product State History#