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Takhzyro

lanadelumab-flyo

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Takhzyro

Proper name

lanadelumab-flyo

Licence type

351(a)

BLA number

761090

Applicant

Takeda Pharmaceuticals U.S.A., Inc.

Center

CDER

Presentations

3

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
150MG/1ML (150MG/ML)	Injection	Subcutaneous	Pre-Filled Syringe	Rx	February 3, 2023
300MG/2ML (150MG/ML)	Injection	Subcutaneous	Single-Dose Vial	Disc	August 23, 2018
300MG/2ML (150MG/ML)	Injection	Subcutaneous	Pre-Filled Syringe	Rx	February 8, 2022

Exclusivity

Source: Purple Book

Kind	Expires
Orphan exclusivity	February 3, 2030

Sources for this page

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