Treats metastatic non-squamous non-small cell lung cancer (NSCLC), with no EGFR or ALK…. ANDA 209085, held by Apotex. Pemetrexed Disodium.
As of Nov 15, 2026, ANDA 209085 (Pemetrexed Disodium), held by Apotex, was first approved by FDA on May 25, 2022, with 3 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 |
|---|---|---|---|
| May 25, 2022 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Pemetrexed DisodiumEQ 1GM BASE/VIAL · powder;intravenous | Pemetrexed Disodium | Discontinued |
| Feb 29, 2024 | Supplement 1Labeling · Standard review | Approved | None posted |
| Feb 29, 2024 | Supplement 2Labeling · Standard review | Approved | None posted |
| Feb 29, 2024 | Supplement 3Labeling · 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
