Alimta

Treats metastatic non-squamous non-small cell lung cancer (NSCLC), with no EGFR or ALK…. NDA 21462, held by Lilly. Pemetrexed Disodium.

As of Nov 15, 2026, NDA 21462 (Alimta), held by Lilly, was first approved by FDA on Feb 4, 2004, with 25 approved supplements and 0 published complete response letters.

First approved: Feb 4, 2004
Review: Priority
Supplements approved: 25
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

ALIMTA 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 26 submissions below


Aug 31, 2022	Supplement 55Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jan 30, 2019	Supplement 53Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jun 4, 2018	Supplement 51Efficacy (new indication or use) · Standard review	Approved	Label Letter
Oct 17, 2012	Supplement 39Efficacy (new indication or use) · Standard review	Approved	Letter Label
Nov 18, 2011	Supplement 29Efficacy (new indication or use) · Standard review	Approved	Label Letter
Mar 17, 2011	Supplement 33Efficacy (new indication or use) · Priority review	Approved	Letter Label
Jul 2, 2009	Supplement 21Efficacy (new indication or use)	Approved	Letter Label
Sep 26, 2008	Supplement 15Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Feb 4, 2004	Original applicationNew molecular entity · Priority review	Approved	Review Letter Patient Package Insert Label

Products

2 strengths and forms


AlimtaEQ 500MG BASE/VIAL · powder;intravenous	Pemetrexed Disodium	RxReference drug
AlimtaEQ 100MG BASE/VIAL · powder;intravenous	Pemetrexed Disodium	RxReference drug

All 26 submissions, including labeling and manufacturing supplements


Aug 31, 2022	Supplement 55Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jan 30, 2019	Supplement 53Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jun 4, 2018	Supplement 51Efficacy (new indication or use) · Standard review	Approved	Label Letter
Apr 17, 2018	Supplement 52Labeling · Standard review	Approved	Label Letter
Oct 11, 2017	Supplement 50Labeling · Standard review	Approved	Label Letter
Jan 8, 2016	Supplement 49Manufacturing · Priority review	Approved	None posted
Aug 11, 2014	Supplement 47Manufacturing · Priority review	Approved	None posted
Sep 12, 2013	Supplement 45Labeling · Standard review	Approved	Label Letter
Mar 13, 2013	Supplement 41Manufacturing · Priority review	Approved	None posted
Jan 18, 2013	Supplement 42Manufacturing · Priority review	Approved	Label
Nov 9, 2012	Supplement 43Labeling · Standard review	Approved	Label Letter
Oct 17, 2012	Supplement 39Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jun 4, 2012	Supplement 40Labeling · Standard review	Approved	Letter Label
Nov 18, 2011	Supplement 32Labeling · Standard review	Approved	Label Letter
Nov 18, 2011	Supplement 30Labeling	Approved	Label Letter
Nov 18, 2011	Supplement 29Efficacy (new indication or use) · Standard review	Approved	Label Letter
Mar 17, 2011	Supplement 33Efficacy (new indication or use) · Priority review	Approved	Letter Label
Jul 2, 2009	Supplement 22Labeling · Standard review	Approved	Label Letter
Jul 2, 2009	Supplement 21Efficacy (new indication or use)	Approved	Letter Label
Jul 2, 2009	Supplement 18Labeling · Standard review	Approved	Label Letter
Sep 26, 2008	Supplement 15Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Sep 7, 2007	Supplement 12Manufacturing	Approved	Label Letter
Feb 2, 2007	Supplement 6Manufacturing	Approved	Label Letter
Jul 28, 2006	Supplement 4Labeling · Standard review	Approved	Label Letter
Aug 19, 2004	Supplement 1Labeling · Standard review	Approved	Letter Label
Feb 4, 2004	Original applicationNew molecular entity · Priority review	Approved	Review Letter Patient Package Insert Label

Identifiers

Application: NDA 21462
Drugs@FDA: Overview at FDA
Company: Lilly

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