Treats amyotrophic lateral sclerosis (ALS). NDA 209080, held by Italfarmaco SA. Riluzole.
As of Nov 13, 2026, NDA 209080 (Tiglutik Kit), held by Italfarmaco SA, was first approved by FDA on Sep 5, 2018, with 3 approved supplements and 0 published complete response letters.
TIGLUTIK is indicated for the treatment of amyotrophic lateral sclerosis (ALS).
| Dec 13, 2019 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| Sep 5, 2018 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Tiglutik Kit50MG/10ML · suspension;oral | Riluzole | RxReference drug |
| Sep 11, 2025 | Supplement 5Labeling · Standard review | Approved | |
| May 11, 2020 | Supplement 3Labeling · Standard review | Approved | |
| Dec 13, 2019 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| Sep 5, 2018 | Original applicationNew dosage form · 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
