Sylvant Purple Book BLA 125496

BLA number: 125496
Proprietary names: Sylvant
Proper names: siltuximab
Applicant: Recordati Rare Diseases, Inc.
Center: CDER
First observed release: 2020-05-01
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	Sylvant	siltuximab	351(a)	100MG	For Injection	Intravenous	Single-Dose Vial	Rx	Licensed	2014-04-23
002	Sylvant	siltuximab	351(a)	400MG	For Injection	Intravenous	Single-Dose Vial	Rx	Licensed	2014-04-23

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
73090-420	Sylvant	Siltuximab	Recordati Rare Diseases, Inc.	current
73090-421	Sylvant	Siltuximab	Recordati Rare Diseases, Inc.	current
57894-420	SYLVANT	siltuximab	Janssen Biotech, Inc.	legacy
57894-421	SYLVANT	siltuximab	Janssen Biotech, Inc.	legacy

Label, Manufacturer, Effective table
Label	Manufacturer	Effective
Sylvant	Recordati Rare Diseases, Inc. \| EUSA Pharma (UK) Ltd \| Cilag AG \| Janssen Biologics B.V. \| Janssen Sciences Ireland Unlimited Company \| Charles River Laboratories, Inc. \| Janssen Biotech, Inc.	2024-08-27
SYLVANT	Janssen Biotech, Inc. \| Janssen Pharmaceuticals, Inc. \| Janssen Biologics BV \| Janssen Sciences Ireland UC \| Cilag AG	2019-06-26

Official Monthly Change Events#

Release, Event, Product table
Release	Event	Product	Name	License type	Status	Applicant
2024-09-01	U	001	Sylvant	351(a)	Rx	Recordati Rare Diseases, Inc.
2024-09-01	U	002	Sylvant	351(a)	Rx	Recordati Rare Diseases, Inc.
2021-05-01	U	001	Sylvant	351(a)	Rx	EUSA Pharma (UK) Limited
2021-05-01	U	002	Sylvant	351(a)	Rx	EUSA Pharma (UK) Limited
2020-08-01	U	001	Sylvant	351(a)	Rx	EUSA Pharma (UK) Ltd.
2020-08-01	U	002	Sylvant	351(a)	Rx	EUSA Pharma (UK) Ltd.
2020-05-01	R	001	Sylvant	351(a)	Rx	EUSA Pharma (UK) Ltd.
2020-05-01	R	002	Sylvant	351(a)	Rx	EUSA Pharma (UK) Ltd.

Observed Product State History#

Release, Product, Name table
Release	Product	Name	License type	Marketing	Licensure	Approval
2020-05-01	001	Sylvant	351(a)	Rx	Licensed	2014-04-23
2020-05-01	002	Sylvant	351(a)	Rx	Licensed	2014-04-23