Treats metastatic non-squamous NSCLC, with no EGFR or ALK genomic tumor aberrations. ANDA 204890, held by Qilu Pharm Hainan. Pemetrexed Disodium.
As of Nov 15, 2026, ANDA 204890 (Pemetrexed Disodium), held by Qilu Pharm Hainan, was first approved by FDA on May 25, 2022, with 1 approved supplement 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 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, non-small cell lung cancer (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 |
| Feb 27, 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
