Is Genetix Biotherapeutics Inc. FDA approved?

Genetix Biotherapeutics Inc. holds no registered establishment of its own; 3 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does Genetix Biotherapeutics Inc. make?

3 products are listed under Genetix Biotherapeutics Inc. in the openFDA NDC Directory, most often as suspension. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Genetix Biotherapeutics Inc.

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

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Registered sites: 0
Active NDC listings: 3
Live patents: 0
Countries: 0

Catalogue

Drug listings by form and route

3 active NDC listings: 3 cellular therapy. By marketing category: BLA 3.

Dosage form	NDCs
suspension	3

Route	NDCs
intravenous	3

Labeller name on the listing	NDCs
genetix biotherapeutics inc.	3

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Lyfgenia	lovotibeglogene autotemcel	suspension, intravenous	73554-1111BLA
Skysona	elivaldogene autotemcel	suspension, intravenous	73554-2111BLA
Zynteglo	betibeglogene autotemcel	suspension, intravenous	73554-3111BLA

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Common questions

Is Genetix Biotherapeutics Inc. FDA approved?: Genetix Biotherapeutics Inc. holds no registered establishment of its own; 3 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does Genetix Biotherapeutics Inc. make?: 3 products are listed under Genetix Biotherapeutics Inc. in the openFDA NDC Directory, most often as suspension. 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.