darolutamide tablets,
for oral use Initial U.S. Approval: 2019

As specified in the prescribing information, darolutamide tablets is indicated for the treatment of prostate cancer. NUBEQA is an androgen receptor inhibitor indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer.

Facts about darolutamide tablets

Approval Date: 2019
Proprietary Name: NUBEQA (darolutamide) tablets
Active Ingredient(s): darolutamide
FDA-approved use: prostate cancer
Dosage Form: Tablets: Tablets: 300 mg
Medicine Approved By: European Medical Agency (EMA), Food and Drug Administration (FDA)
Manufacturer: Bayer
Summary of FDA-approved use on approval date: Click Here
(see Drugs@FDA for complete indication)

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