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QALSODY

NDA · New Drug Application · Sponsor: BIOGEN MA · Approved 2023-04-25

Drug application

FDA Application #

NDA215887

Application type

New Drug Application

Brand name

QALSODY

Generic name

TOFERSEN

Active ingredients

TOFERSEN

Dosage form

SOLUTION

Route

INTRATHECAL

Marketing status

Prescription

Sponsor

BIOGEN MA

Manufacturer

Biogen Inc.

First approval

2023-04-25

Source

Authoritative

Drugs@FDA application overview

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