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Treats metastatic non-squamous non-small cell lung cancer (NSCLC), with no EGFR or ALK…. ANDA 215460, held by Hetero Labs Ltd Vi. Pemetrexed Disodium.
As of Nov 15, 2026, ANDA 215460 (Pemetrexed Disodium), held by Hetero Labs Ltd Vi, was first approved by FDA on Jun 14, 2024, with 0 approved supplements and 0 published complete response letters.
First approved: Jun 14, 2024
Review: Standard
Supplements approved: 0
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 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.
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
