Is Biogen MA Inc. FDA approved?

Biogen MA Inc. holds no registered establishment of its own; 6 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does Biogen MA Inc. make?

6 products are listed under Biogen MA Inc. in the openFDA NDC Directory, most often as capsule; injection. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Biogen MA Inc.

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

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Registered sites: 0
Active NDC listings: 6
Labeller names: 2
Live patents: 3
Exclusivities: 1
Countries: 0

Catalogue

Drug listings by form and route

6 active NDC listings: 6 human prescription drug. By marketing category: BLA 3, NDA 3.

Dosage form	NDCs
capsule	3
injection	3

Route	NDCs
intravenous	3
oral	3

Labeller name on the listing	NDCs
biogen ma inc	3
biogen ma inc.	3

Exclusivity

Patents and exclusivities

Patent	Product	Covers	Expiry
10385341	QALSODYtofersen	substance, product	Apr 2035
10669546	QALSODYtofersen	use	Apr 2035
10968453	QALSODYtofersen	use	Apr 2035

Product	Exclusivity	Until
QALSODYTOFERSEN	ODE-432 Orphan drug	Apr 2030

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Tofidence	Tocilizumab	injection, intravenous	64406-022BLA
Tofidence	Tocilizumab	injection, intravenous	64406-023BLA
Tofidence	Tocilizumab	injection, intravenous	64406-024BLA
ZURZUVAE	zuranolone	capsule, oral	64406-029NDA
ZURZUVAE	zuranolone	capsule, oral	64406-030NDA
ZURZUVAE	zuranolone	capsule, oral	64406-031NDA

Compare

Other companies listing tocilizumab

Lonza Biologics Inc15 sites · 80 NDC
Genentech, Inc.8 sites · 93 NDC
Chugai Pharmaceutical Co., Ltd.3 sites · 13 NDC
Genentech, Inc. (SSF)0 sites · 2 NDC

Enquiry

Common questions

Is Biogen MA Inc. FDA approved?: Biogen MA Inc. holds no registered establishment of its own; 6 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does Biogen MA Inc. make?: 6 products are listed under Biogen MA Inc. in the openFDA NDC Directory, most often as capsule; injection. 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.