← FDA DRUG APPROVALS

FDA NDA · NDA215904

ZTALMY

ganaxolone

Sponsor: IMMEDICA PHARMA

APPLICATION
NDA215904
TYPE
NDA
ORIGINAL APPROVAL
2022-03-18
LATEST ACTION
2025-10-16
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Prescription

Products

ZTALMY · ReferencePrescription
GANAXOLONE 50MG/ML · SUSPENSION · ORAL

Approval history

2025-10-16Labeling · Supplement 13 · standard — Letter ↗AP
2025-10-16Efficacy · Supplement 11 · standard — Letter ↗AP
2025-08-06Labeling · Supplement 12 · standard — Letter ↗AP
2023-06-21Labeling · Supplement 4 · standard — Letter ↗AP
2023-06-21Labeling · Supplement 3 · standard — Letter ↗AP
2022-11-09Labeling · Supplement 2 · standard — Label ↗AP
2022-11-09Labeling · Supplement 1 · standard — Label ↗AP
2022-03-18Type 1 - New Molecular Entity · Original · priority — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA 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 →