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  • Drug Approval Package: Erleada (apalutamide) - Fda

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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER:204441Orig1s000 REMSRisk Evaluation and Mitigation Strategy (REMS) Document JYNARQUE () REMS ProgramI.Administrative InformationApplication.

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Erleada (apalutamide) is usually taken until cancer progresses past a certain point or you start to have unacceptable side effects. In the SPARTAN clinical trial (NCT01946204) using apalutamide for men with castration-resistant metastasis-free prostate cancer, some patients were still using apalutamide at 36 months.

The recommended dose of ERLEADA is 240 mg (four 60 mg tablets) administered orally once daily. Swallow the tablets whole. ERLEADA can be taken with or without food. Patients should also receive a -releasing hormone (GnRH) analog concurrently or should have had a bilateral orchiectomy.

Apalutamide was approved by the Food and Drug Administration in the United States, under the brand name Erleada, for the treatment of NM-CRPC on 14 February 2018.

On February 14, the Food and Drug Administration (FDA) approved apalutamide (Erleada) for men with prostate cancer that has not spread (nonmetastatic) and is resistant to standard hormone therapy, also called androgen deprivation therapy (ADT).

Apalutamide was initially approved in 2018 for patients with non-metastatic castration-resistant prostate cancer.

Erleada First Treatment for Nonmetastatic Prostate Cancer The FDA approval of apalutamide is the first time the FDA used the clinical end point of metastasisfree survival as the basis for a drug approval.

FDA approves darolutamide tablets for metastatic hormone-sensitive prostate cancer. On August 5, 2022, the Food and Drug Administration approved darolutamide (Nubeqa, Bayer HealthCare Pharmaceuticals Inc.) tablets in combination with for adult patients with metastatic hormone-sensitive prostate cancer (mHSPC) ...

DrugPatentWatch® Generic Entry Outlook for Erleada. Erleada was eligible for patent challenges on February 14, 2022. By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 4, 2033. This may change due to patent challenges or generic licensing.

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Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
DMCA Policy
About Us
Blog
Affiliates
Contact Us
Privacy Notice
Delete My Account
Site Map
Industries
Forms in Spanish
Localized Forms
State-specific Forms
Forms Kit
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate workflows
DocHub
Instapage
Social Media
Call us now toll free:
1-877-389-0141
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232