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Kisqali FDA Approval History

FDA Approved: Yes (First approved March 13, 2017)
Brand name: Kisqali
Generic name: ribociclib
Dosage form: Tablets
Previous Name: LEE011
Company: Novartis Pharmaceuticals Corporation
Treatment for: Breast Cancer

Kisqali (ribociclib) is an inhibitor of cyclin-dependent kinase (CDK) 4 and 6 indicated for the combination treatment of pre/perimenopausal or postmenopausal women with HR+/HER2- metastatic breast cancer.

Development Timeline for Kisqali

DateArticle
Jul 18, 2018Approval Kisqali (ribociclib) Approved for Additional Indications in HR+/HER2- Advanced Breast Cancer
Mar 13, 2017Approval FDA Approves Kisqali (ribociclib) for HR+/HER2- Metastatic Breast Cancer

Further information

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