Treats metastatic non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor…. ANDA 203485, held by Accord Hlthcare. Pemetrexed Disodium.
As of Nov 15, 2026, ANDA 203485 (Pemetrexed Disodium), held by Accord Hlthcare, was first approved by FDA on May 25, 2022, with 2 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-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 |
|---|---|---|---|
| May 25, 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 1GM BASE/VIAL · powder;intravenous | Pemetrexed Disodium | Rx |
| Aug 6, 2025 | Supplement 4Labeling · Standard review | Approved | None posted |
| Aug 29, 2023 | Supplement 2Labeling · Standard review | Approved | None posted |
| May 25, 2022 | Original application | Approved | None posted |
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
