Pemetrexed Disodium

Treats locally advanced or metastatic, non-squamous, non-small cell lung cancer (NSCLC). NDA 214218, held by Hospira. Pemetrexed Disodium.

As of Nov 14, 2026, NDA 214218 (Pemetrexed Disodium), held by Hospira, was first approved by FDA on Jun 22, 2022, with 0 approved supplements and 0 published complete response letters.

First approved: Jun 22, 2022
Review: Standard
Supplements approved: 0
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 cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous, non-small cell lung cancer (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.
As a single agent for the treatment of patients with recurrent, metastatic non-squamous, NSCLC after prior chemotherapy.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first

Date	Submission	Status	Documents
Jun 22, 2022	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Label Letter

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

Identifiers

Application: NDA 214218
Drugs@FDA: Overview at FDA
Company: Hospira

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