Pemetrexed Disodium

Treats metastatic non-squamous non-small cell lung cancer (NSCLC), with no EGFR or ALK…. ANDA 90384, held by Fresenius Kabi USA. Pemetrexed Disodium.

As of Nov 15, 2026, ANDA 90384 (Pemetrexed Disodium), held by Fresenius Kabi USA, was first approved by FDA on May 25, 2022, with 1 approved supplement and 0 published complete response letters.

First approved: May 25, 2022
Supplements approved: 1
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Pemetrexed for 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 2 submissions below

Date	Submission	Status	Documents
May 25, 2022	Original application	Approved	Letter

Products

4 strengths and forms


Pemetrexed DisodiumEQ 100MG BASE/VIAL · powder;intravenous	Pemetrexed Disodium	Rx
Pemetrexed DisodiumEQ 500MG BASE/VIAL · powder;intravenous	Pemetrexed Disodium	Rx
Pemetrexed DisodiumEQ 750MG BASE/VIAL · powder;intravenous	Pemetrexed Disodium	Rx
Pemetrexed DisodiumEQ 1GM BASE/VIAL · powder;intravenous	Pemetrexed Disodium	Rx

All 2 submissions, including labeling and manufacturing supplements


Sep 25, 2023	Supplement 1Labeling · Standard review	Approved	None posted
May 25, 2022	Original application	Approved	Letter

Identifiers

Application: ANDA 90384
Drugs@FDA: Overview at FDA
Company: Fresenius Kabi USA

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