NDA 217604, held by Amneal. Pyridostigmine Bromide.
As of Nov 14, 2026, NDA 217604 (Pyridostigmine Bromide), held by Amneal, was first approved by FDA on Oct 4, 2024, with 1 approved supplement and 0 published complete response letters.
Pyridostigmine bromide is indicated for pretreatment against the lethal effects of soman nerve agent poisoning in adults. Pyridostigmine bromide is intended for use in conjunction with protective garments, including a mask. At the first sign of nerve agent poisoning, pyridostigmine bromide should be stopped, and atropine and pralidoxime therapy started immediately. The evidence for the effectiveness of pyridostigmine bromide as pretreatment against soman-induced toxicity was derived from animal studies alone. FOR MILITARY MEDICAL USE ONLY
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 4, 2024 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Pyridostigmine Bromide105MG · tablet, extended release;oral | Pyridostigmine Bromide | Discontinued |
| May 12, 2026 | Supplement 6Labeling · Standard review | Approved | |
| Oct 4, 2024 | 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
