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FDA NDA · NDA210661

AXTLE

pemetrexed

Sponsor: AVYXA HOLDINGS

APPLICATION
NDA210661
TYPE
NDA
ORIGINAL APPROVAL
2024-06-28
LATEST ACTION
2025-10-03
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

AXTLE · ReferencePrescription
PEMETREXED DIPOTASSIUM EQ 100MG BASE/VIAL · POWDER · INTRAVENOUS
AXTLE · ReferencePrescription
PEMETREXED DIPOTASSIUM EQ 500MG BASE/VIAL · POWDER · INTRAVENOUS

Approval history

2025-10-03Efficacy · Supplement 4 · standard — Letter ↗AP
2025-06-18Labeling · Supplement 3 · standard — Label ↗AP
2024-12-02Labeling · Supplement 1 · standard — Label ↗AP
2024-06-28Type 2 - New Active Ingredient · 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.

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