BLA 125504, held by Novartis Pharms Corp. Secukinumab.
As of Nov 13, 2026, BLA 125504 (Cosentyx), held by Novartis Pharms Corp, was first approved by FDA on Jan 21, 2015, with 25 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 17, 2026 | Supplement 98Efficacy (new indication or use) · Priority review | Approved | |
| Apr 17, 2026 | Supplement 97Efficacy (new indication or use) · Priority review | Approved | |
| Mar 12, 2026 | Supplement 91Efficacy (new indication or use) · Standard review | Approved | |
| Oct 31, 2023 | Supplement 63Efficacy (new indication or use) · Standard review | Approved | |
| May 11, 2023 | Supplement 44Efficacy (new indication or use) · Standard review | Approved | |
| Dec 22, 2021 | Supplement 51Efficacy (new indication or use) · Priority review | Approved | |
| Dec 22, 2021 | Supplement 50Efficacy (new indication or use) · Priority review | Approved | |
| May 28, 2021 | Supplement 43Efficacy (new indication or use) · Standard review | Approved | |
| Jun 16, 2020 | Supplement 35Efficacy (new indication or use) · Priority review | Approved | |
| Jan 29, 2020 | Supplement 31Efficacy (new indication or use) · Standard review | Approved | |
| Jun 19, 2018 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Jan 23, 2018 | Supplement 13Efficacy (new indication or use) · Standard review | Approved | |
| Jan 15, 2016 | Supplement 2Efficacy (new indication or use) | Approved | |
| Jan 15, 2016 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| Jan 21, 2015 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Cosentyx150MG/ML · injectable;injection | Secukinumab | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 15, 2026 | Supplement 99Labeling · Standard review | Approved | |
| Apr 17, 2026 | Supplement 98Efficacy (new indication or use) · Priority review | Approved | |
| Apr 17, 2026 | Supplement 97Efficacy (new indication or use) · Priority review | Approved | |
| Mar 12, 2026 | Supplement 91Efficacy (new indication or use) · Standard review | Approved | |
| Aug 6, 2025 | Supplement 88Labeling · Standard review | Approved | |
| Mar 12, 2025 | Supplement 84Labeling · Standard review | Approved | |
| Oct 4, 2024 | Supplement 80Labeling · Standard review | Approved | |
| Aug 16, 2024 | Supplement 82Labeling · Standard review | Approved | |
| Nov 21, 2023 | Supplement 66Labeling · Standard review | Approved | |
| Oct 31, 2023 | Supplement 63Efficacy (new indication or use) · Standard review | Approved | |
| Oct 6, 2023 | Supplement 73Labeling · Standard review | Approved | |
| Jul 24, 2023 | Supplement 67Manufacturing | Approved | |
| Jul 24, 2023 | Supplement 55Labeling · Standard review | Approved | |
| Jul 24, 2023 | Supplement 54Labeling · Standard review | Approved | |
| May 11, 2023 | Supplement 44Efficacy (new indication or use) · Standard review | Approved | |
| Dec 22, 2021 | Supplement 51Efficacy (new indication or use) · Priority review | Approved | |
| Dec 22, 2021 | Supplement 50Efficacy (new indication or use) · Priority review | Approved | |
| May 28, 2021 | Supplement 43Efficacy (new indication or use) · Standard review | Approved | |
| Jun 16, 2020 | Supplement 35Efficacy (new indication or use) · Priority review | Approved | |
| Jan 29, 2020 | Supplement 31Efficacy (new indication or use) · Standard review | Approved | |
| Jun 19, 2018 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Jan 23, 2018 | Supplement 13Efficacy (new indication or use) · Standard review | Approved | |
| Sep 15, 2017 | Supplement 16Labeling · Standard review | Approved | |
| Jan 15, 2016 | Supplement 2Efficacy (new indication or use) | Approved | |
| Jan 15, 2016 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| Jan 21, 2015 | Original applicationNew molecular entity · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
