Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 209935
Company: NOVARTIS
Company: NOVARTIS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
KISQALI FEMARA CO-PACK (COPACKAGED) | LETROZOLE; RIBOCICLIB SUCCINATE | 2.5MG;EQ 200MG BASE | TABLET;ORAL | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
05/04/2017 | ORIG-1 | Approval | Type 4 - New Combination | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209935s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209935Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209935Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/11/2025 | SUPPL-29 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/209092Orig1s023,209935Orig1s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/209092Orig1s023,209935Orig1s029ltr.pdf | |
09/03/2024 | SUPPL-28 | Manufacturing (CMC)-Facility |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209092Orig1s020, 209935Orig1s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/209092Orig1s020, 209935Orig1s028ltr.pdf | |
09/17/2024 | SUPPL-27 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209935Orig1s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/209092Orig1s018, 209935Orig1s027ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/209092s018,209935s027MultidisciplineR.pdf | |
08/24/2023 | SUPPL-25 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209935s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/209092Orig1s016;209935Orig1s025ltr.pdf | |
10/03/2022 | SUPPL-21 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209092s013,209935s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209092Orig1s013,209935Orig1s021ltr.pdf | |
05/04/2022 | SUPPL-19 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209935Orig1s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209935Orig1s019ltr.pdf | |
12/10/2021 | SUPPL-14 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209935s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/209092Orig1s008;209935Orig1s014ltr.pdf | |
09/15/2021 | SUPPL-13 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209935s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/209092Orig1s009; 209935Orig1s013ltr.pdf | |
07/06/2020 | SUPPL-8 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209935s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209092Orig1s005, 209935Orig1s008ltr.pdf | |
09/09/2019 | SUPPL-7 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209935s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209935Orig1s007ltr.pdf | |
01/21/2020 | SUPPL-6 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209935s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209092Orig1s003, 209935Orig1s006ltr.pdf | |
02/13/2019 | SUPPL-2 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209935s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209935Orig1s002ltr.pdf | |
04/23/2018 | SUPPL-1 | Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209935s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209935Orig1s001ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
02/11/2025 | SUPPL-29 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/209092Orig1s023,209935Orig1s029lbl.pdf | |
09/17/2024 | SUPPL-27 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209935Orig1s027lbl.pdf | |
09/03/2024 | SUPPL-28 | Manufacturing (CMC)-Facility | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209092Orig1s020, 209935Orig1s028lbl.pdf | |
08/24/2023 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209935s025lbl.pdf | |
10/03/2022 | SUPPL-21 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209092s013,209935s021lbl.pdf | |
05/04/2022 | SUPPL-19 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209935Orig1s019lbl.pdf | |
12/10/2021 | SUPPL-14 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209935s014lbl.pdf | |
09/15/2021 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209935s013lbl.pdf | |
07/06/2020 | SUPPL-8 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209935s008lbl.pdf | |
01/21/2020 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209935s006lbl.pdf | |
09/09/2019 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209935s007lbl.pdf | |
02/13/2019 | SUPPL-2 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209935s002lbl.pdf | |
04/23/2018 | SUPPL-1 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209935s001lbl.pdf | |
05/04/2017 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209935s000lbl.pdf |