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Kesimpta

ofatumumab

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Kesimpta

Proper name

ofatumumab

Licence type

351(a)

BLA number

125326

Applicant

Novartis Pharmaceuticals Corporation

Center

CDER

Presentations

2

First licensure

—

Presentations

Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
20MG/0.4ML	Injection	Subcutaneous	Autoinjector	Rx	August 20, 2020
20MG/0.4ML	Injection	Subcutaneous	Pre-Filled Syringe	Disc	August 20, 2020

Sources for this page

Purple Book	FDA	Licence type, presentations, reference product, exclusivity