Treats metastatic non-squamous non-small cell lung cancer (NSCLC), with no EGFR or ALK…. NDA 215179, held by Shilpa. Pemetrexed Disodium.
As of Nov 14, 2026, NDA 215179 (Pemetrexed), held by Shilpa, was first approved by FDA on May 22, 2023, with 1 approved supplement and 2 published complete response letters.
1. INDICATIONS AND USAGE PEMRYDI RTU 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 22, 2023 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Apr 14, 2022 | PemetrexedProduct Quality | Approved |
| Jun 24, 2021 | PemetrexedProduct Quality, Facility Inspections | Approved |
| PemetrexedEQ 100MG/10ML BASE (10MG/ML) · solution;intravenous | Pemetrexed Disodium | RxReference drug |
| PemetrexedEQ 500MG/50ML BASE (10MG/ML) · solution;intravenous | Pemetrexed Disodium | RxReference drug |
| PemetrexedEQ 1GM/100ML BASE (10MG/ML) · solution;intravenous | Pemetrexed Disodium | RxReference drug |
| Nov 15, 2024 | Supplement 2Labeling · Standard review | Approved | |
| May 22, 2023 | Original applicationNew formulation or manufacturer · Standard review | Approved |
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
