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DAWNZERA (AUTOINJECTOR)

NDA · New Drug Application · Sponsor: IONIS PHARMS INC · Approved 2025-08-21

Drug application

FDA Application #

NDA219407

Application type

New Drug Application

Brand name

DAWNZERA (AUTOINJECTOR)

Generic name

DONIDALORSEN

Active ingredients

DONIDALORSEN SODIUM

Dosage form

SOLUTION

Route

SUBCUTANEOUS

Marketing status

Prescription

Sponsor

IONIS PHARMS INC

Manufacturer

Ionis Pharmaceuticals Inc.

First approval

2025-08-21

Source

Authoritative

Drugs@FDA application overview

Machine

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