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Erleada Approval History

FDA Approved: Yes (First approved February 14, 2018)
Brand name: Erleada
Generic name: apalutamide
Dosage form: Tablets
Company: Janssen Pharmaceuticals, Inc.
Treatment for: Prostate Cancer

Erleada (apalutamide) is an oral androgen receptor inhibitor for the treatment of metastatic castration-sensitive prostate cancer, and non-metastatic castration-resistant prostate cancer.

Development History and FDA Approval Process for Erleada

DateArticle
Sep 17, 2019Approval FDA Approves Erleada (apalutamide) for the Treatment of Patients with Metastatic Castration-Sensitive Prostate Cancer (mCSPC)
Feb 14, 2018Approval FDA Approves Erleada (apalutamide) for Non-Metastatic Castration-Resistant Prostate Cancer
Oct 11, 2017Janssen Submits New Drug Application to U.S. FDA for Apalutamide (ARN-509) to Treat Men with Non-Metastatic Castration-Resistant Prostate Cancer
Oct  1, 2012Aragon Pharmaceuticals Announces Clinical Results from Ongoing Phase II Trial Confirming Robust Anti-Tumor Activity and Tolerability of ARN-509 in Three Different Patient Populations of Castration Resistant Prostate Cancer

Further information

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