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Nubeqa Approval History

FDA Approved: Yes (First approved July 30, 2019)
Brand name: Nubeqa
Generic name: darolutamide
Dosage form: Tablets
Company: Bayer HealthCare Pharmaceuticals Inc.
Treatment for: Prostate Cancer

Nubeqa (darolutamide) is an androgen receptor inhibitor (ARi) indicated for the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC).

Development History and FDA Approval Process for Nubeqa

DateArticle
Jul 30, 2019Approval FDA Approves Nubeqa (darolutamide) for Men with Non-Metastatic Castration-Resistant Prostate Cancer
Apr 29, 2019U.S. FDA Accepts New Drug Application and Grants Priority Review for Darolutamide
Feb 27, 2019Bayer Completes Rolling Submission of NDA for Investigational Drug Darolutamide for the Treatment of Non-Metastatic Castration-Resistant Prostate Cancer (nmCRPC)
Oct 24, 2018Phase III Trial of Darolutamide in Patients with Non-metastatic Castration-resistant Prostate Cancer Meets Primary Endpoint

Further information

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