NDA 20961, held by Novartis. Fomivirsen Sodium.
As of Nov 14, 2026, NDA 20961 (Vitravene Preservative Free), held by Novartis, was first approved by FDA on Aug 26, 1998, with 3 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 26, 1998 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Vitravene Preservative Free6.6MG/ML · injectable;injection | Fomivirsen Sodium | Discontinued |
| Apr 27, 2001 | Supplement 4Manufacturing · Priority review | Approved | None posted |
| Jul 31, 2000 | Supplement 3Manufacturing · Priority review | Approved | None posted |
| Feb 22, 1999 | Supplement 1Manufacturing · Priority review | Approved | None posted |
| Aug 26, 1998 | Original applicationNew molecular entity · Priority 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
