← FDA Drug Approvals (Drugs@FDA)

PRALUENT

BLA · Biologics License Application · Sponsor: REGENERON PHARMACEUTICALS · Approved 2015-07-24

Drug application

FDA Application #

BLA125559

Application type

Biologics License Application

Brand name

PRALUENT

Generic name

ALIROCUMAB

Active ingredients

ALIROCUMAB

Dosage form

INJECTABLE

Route

INJECTION

Marketing status

Prescription

Sponsor

REGENERON PHARMACEUTICALS

Manufacturer

Regeneron Pharmaceuticals, Inc.

First approval

2015-07-24

Source

Authoritative

Drugs@FDA application overview

Machine

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