← FDA DRUG APPROVALS

FDA NDA · NDA215887

QALSODY

tofersen

Sponsor: BIOGEN MA

APPLICATION
NDA215887
TYPE
NDA
ORIGINAL APPROVAL
2023-04-25
LATEST ACTION
2023-04-25
ROUTE
INTRATHECAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

QALSODY · ReferencePrescription
TOFERSEN 100MG/15ML (6.7MG/ML) · SOLUTION · INTRATHECAL

Approval history

2023-04-25Type 1 - New Molecular Entity · Original · priorityLabelAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA enforcement & recalls

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →