Pemetrexed Disodium

Treats metastatic non-squamous non-small cell lung cancer (NSCLC), with no EGFR or ALK…. NDA 214657, held by Sandoz. Pemetrexed Disodium.

As of Nov 13, 2026, NDA 214657 (Pemetrexed Disodium), held by Sandoz, was first approved by FDA on May 26, 2022, with 2 approved supplements and 0 published complete response letters.

First approved: May 26, 2022
Review: Standard
Supplements approved: 2
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Pemetrexed Injection is a folate analog metabolic inhibitor indicated:

in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.
in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous NSCLC.
as a single agent for the maintenance treatment of patients with locally advanced or metastatic, non-squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
May 26, 2022	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Letter Label

Products

3 strengths and forms


Pemetrexed DisodiumEQ 100MG BASE/4ML (EQ 25MG BASE/ML) · solution;intravenous	Pemetrexed Disodium	RxReference drug
Pemetrexed DisodiumEQ 500MG BASE/20ML (EQ 25MG BASE/ML) · solution;intravenous	Pemetrexed Disodium	RxReference drug
Pemetrexed DisodiumEQ 1GM BASE/40ML (EQ 25MG BASE/ML) · solution;intravenous	Pemetrexed Disodium	RxReference drug

All 3 submissions, including labeling and manufacturing supplements


Dec 15, 2025	Supplement 6Labeling · Standard review	Approved	Letter Label
Apr 21, 2023	Supplement 3Labeling · Standard review	Approved	Letter Label
May 26, 2022	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 214657
Drugs@FDA: Overview at FDA
Company: Sandoz

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters