NDA 21677, held by Lilly. Pemetrexed.
As of Nov 14, 2026, NDA 21677 (Alimta), held by Lilly, was first approved by FDA on Aug 19, 2004, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 19, 2004 | Original applicationNew indication · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Alimta500MG · injectable; injection | Pemetrexed | Rx |
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
