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Treats metastatic non-squamous non-small cell lung cancer (NSCLC), with no EGFR or ALK…. ANDA 216582, held by Prinston. Pemetrexed Disodium.
As of Nov 15, 2026, ANDA 216582 (Pemetrexed Disodium), held by Prinston, was first approved by FDA on Dec 11, 2023, with 0 approved supplements and 0 published complete response letters.
First approved: Dec 11, 2023
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, 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.
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
