← FDA DRUG APPROVALS

FDA NDA · NDA217684

VIGAFYDE

vigabatrin

Sponsor: PYROS PHARMS

APPLICATION
NDA217684
TYPE
NDA
ORIGINAL APPROVAL
2024-06-17
LATEST ACTION
2026-03-18
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

VIGAFYDE · ReferencePrescription
VIGABATRIN 100MG/ML · SOLUTION · ORAL

Approval history

2026-03-18REMS · Supplement 7 — Letter ↗AP
2025-09-03Efficacy · Supplement 2 · standard — Letter ↗AP
2025-09-03Labeling · Supplement 4 · standard — Letter ↗AP
2024-09-12REMS · Supplement 1 — Letter ↗AP
2024-06-17Type 3 - New Dosage Form · Original · standard — 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 →