Treats metastatic non-squamous non-small cell lung cancer (NSCLC), with no EGFR or ALK…. Sold as Axtle. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Pemetrexed Dipotassium (sold as Axtle), first approved Jun 28, 2024, with 1 new use approved and 0 published complete response letters.
| AXTLE | Part B | $8.5M | New | 350 |
| Axtle | Part D | $0K | New | 0 |
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Jun 28, 2024 | AxtleNDA 210661 · New active ingredient | Avyxa Holdings | 3 | Marketed |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
