Is Swedish Orphan Biovitrum AB (publ) FDA approved?

Swedish Orphan Biovitrum AB (publ) holds no registered establishment of its own; 15 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does Swedish Orphan Biovitrum AB (publ) make?

15 products are listed under Swedish Orphan Biovitrum AB (publ) in the openFDA NDC Directory, most often as injection; capsule; injection, powder, lyophilized, for solution. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Swedish Orphan Biovitrum AB (publ)

Data as of 24 Sept 2026 · How to read this entry

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Registered sites: 0
Active NDC listings: 14
Labeller names: 2
Live patents: 1
Countries: 0

Catalogue

Drug listings by form and route

14 active NDC listings: 14 human prescription drug. By marketing category: BLA 9, NDA 5.

Dosage form	NDCs
injection	7
capsule	4
injection, powder, lyophilized, for solution	1
injection, solution	1
suspension	1

Route	NDCs
intravenous	8
oral	5
subcutaneous	1

Labeller name on the listing	NDCs
swedish orphan biovitrum ab (publ)	10
swedish orphan biovitrum ab (publ)	4

Exclusivity

Patents and exclusivities

Patent	Product	Covers	Expiry
9301932	ORFADINnitisinone	product	Feb 2033

Catalogue

Marketed products

Showing 14 of 15.

Brand	Generic name	Form / route	NDC
GAMIFANT	emapalumab-lzsg	injection, intravenous	66658-501BLA
GAMIFANT	emapalumab-lzsg	injection, intravenous	66658-505BLA
GAMIFANT	emapalumab-lzsg	injection, intravenous	66658-510BLA
GAMIFANT	emapalumab-lzsg	injection, intravenous	66658-522BLA
GAMIFANT	emapalumab-lzsg	injection, intravenous	66658-523BLA
GAMIFANT	emapalumab-lzsg	injection, intravenous	66658-524BLA
GAMIFANT	emapalumab-lzsg	injection, intravenous	66658-525BLA
KEPIVANCE	palifermin	injection, powder, lyophilized, for solution, intravenous	66658-113BLA
Kineret	anakinra	injection, solution, subcutaneous	66658-234BLA
ORFADIN	nitisinone	suspension, oral	66658-204NDA
Orfadin	Nitisinone	capsule, oral	66658-102NDA
Orfadin	Nitisinone	capsule, oral	66658-105NDA
Orfadin	Nitisinone	capsule, oral	66658-110NDA
Orfadin	Nitisinone	capsule, oral	66658-120NDA

Enquiry

Common questions

Is Swedish Orphan Biovitrum AB (publ) FDA approved?: Swedish Orphan Biovitrum AB (publ) holds no registered establishment of its own; 15 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does Swedish Orphan Biovitrum AB (publ) make?: 15 products are listed under Swedish Orphan Biovitrum AB (publ) in the openFDA NDC Directory, most often as injection; capsule; injection, powder, lyophilized, for solution. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.