Treats metastatic non-squamous non-small cell lung cancer (NSCLC), with no EGFR or ALK…. ANDA 215479, held by Meitheal. Pemetrexed Disodium.
As of Nov 15, 2026, ANDA 215479 (Pemetrexed Disodium), held by Meitheal, was first approved by FDA on Dec 13, 2022, with 0 approved supplements and 0 published complete response letters.
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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 13, 2022 | Original application | Approved | None posted |
| 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 |
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
