Lowers the risk of death associated with acute ST elevation myocardial infarction (STEMI). BLA 103909, held by Genentech. Tenecteplase.
As of Nov 13, 2026, BLA 103909 (Tnkase), held by Genentech, was first approved by FDA on Jun 2, 2000, with 5 approved supplements and 0 published complete response letters.
TNKase is indicated to reduce the risk of death associated with acute ST elevation myocardial infarction (STEMI).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 28, 2025 | Supplement 5197Efficacy (new indication or use) · Standard review | Approved | |
| Jun 2, 2000 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Tnkase50MG/VIAL · vial | Tenecteplase | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 28, 2025 | Supplement 5197Efficacy (new indication or use) · Standard review | Approved | |
| Jan 5, 2024 | Supplement 5195Labeling · Standard review | Approved | |
| Mar 31, 2023 | Supplement 5194Labeling · Standard review | Approved | |
| Feb 28, 2018 | Supplement 5187Labeling · Standard review | Approved | |
| May 13, 2008 | Supplement 5109Labeling · Standard review | Approved | None posted |
| Jun 2, 2000 | Original applicationNew molecular entity · 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
