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Repatha

evolocumab

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Repatha

Proper name

evolocumab

Licence type

351(a)

BLA number

125522

Applicant

Amgen Inc.

Center

CDER

Presentations

4

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
140MG/ML	Injection	Subcutaneous	Pre-Filled Syringe	Rx	August 27, 2015
140MG/ML	Injection	Subcutaneous	Autoinjector	Disc	August 27, 2015
140MG/ML	Injection	Subcutaneous	Autoinjector	Rx	July 13, 2026
420MG/3.5ML	Injection	Subcutaneous	Autoinjector	Disc	July 8, 2016

Exclusivity

Source: Purple Book

Kind	Expires
Orphan exclusivity	September 24, 2028

Sources for this page

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