NDA 209935, held by Novartis. Letrozole; Ribociclib Succinate.
As of Nov 13, 2026, NDA 209935 (Kisqali Femara Co-Pack (Copackaged)), held by Novartis, was first approved by FDA on May 4, 2017, with 16 approved supplements and 0 published complete response letters.
| Jul 1, 2026 | Supplement 33Efficacy (new indication or use) · Priority review | Approved | |
| Sep 17, 2024 | Supplement 27Efficacy (new indication or use) · Standard review | Approved | |
| Oct 3, 2022 | Supplement 21Efficacy (new indication or use) · Standard review | Approved | |
| Dec 10, 2021 | Supplement 14Efficacy (new indication or use) · Standard review | Approved | |
| Jul 6, 2020 | Supplement 8Efficacy (new indication or use) · Standard review | Approved | |
| Feb 13, 2019 | Supplement 2Efficacy (new indication or use) · Priority review | Approved | |
| May 4, 2017 | Original applicationNew combination · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Kisqali Femara Co-Pack (Copackaged)2.5MG;EQ 200MG BASE · tablet;oral | Letrozole; Ribociclib Succinate | RxReference drug |
| Jul 1, 2026 | Supplement 33Efficacy (new indication or use) · Priority review | Approved | |
| Sep 16, 2025 | Supplement 31Manufacturing | Approved | |
| Jul 28, 2025 | Supplement 30Labeling · Standard review | Approved | |
| Feb 11, 2025 | Supplement 29Labeling · Standard review | Approved | |
| Sep 17, 2024 | Supplement 27Efficacy (new indication or use) · Standard review | Approved | |
| Sep 3, 2024 | Supplement 28Manufacturing | Approved | |
| Aug 24, 2023 | Supplement 25Labeling · Standard review | Approved | |
| Oct 3, 2022 | Supplement 21Efficacy (new indication or use) · Standard review | Approved | |
| May 4, 2022 | Supplement 19Labeling · Standard review | Approved | |
| Dec 10, 2021 | Supplement 14Efficacy (new indication or use) · Standard review | Approved | |
| Sep 15, 2021 | Supplement 13Labeling · Standard review | Approved | |
| Jul 6, 2020 | Supplement 8Efficacy (new indication or use) · Standard review | Approved | |
| Jan 21, 2020 | Supplement 6Labeling · Standard review | Approved | |
| Sep 9, 2019 | Supplement 7Labeling · Standard review | Approved | |
| Feb 13, 2019 | Supplement 2Efficacy (new indication or use) · Priority review | Approved | |
| Apr 23, 2018 | Supplement 1Labeling · Standard review | Approved | |
| May 4, 2017 | Original applicationNew combination · 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
