FDA receives additional marketing application for Janssen ZYTIGA
Janssen Research & Development has announced that it has submitted a supplemental New Drug Application to FDA for ZYTIGA(abiraterone acetate).
Janssen-Cilag International NV has also sent a type II variation to the European Medicines Agency (EMA) for approval.
The two applications are intended to increase the uses of ZYTIGA administered with prednisone to include the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC).
Since its first approval in the U.S. in 2011, ZYTIGA has got approval in more than 45 countries. The filing of sNDA was completed by Janssen Research & Development on behalf of Janssen Biotech.
ZYTIGA Vice President Michael L. Meyers said,"We're delighted to move forward so quickly with these regulatory submissions, building on the momentum created by the data presentation two weeks ago."
"We look forward to working with the FDA and EMA to make ZYTIGA available for men with metastatic prostate cancer earlier in the course of their disease," Michael added.
Drug Research Drug Delivery Drug Discovery & Development
Contract Research & Services Clinical Trials Contract Research Contract Services
Automation IT & Software Laboratory Instrumentation
Inward Investment Packaging Regulatory Affairs
ICD Research's "UnitedHealth Group Incorporated: Pharmaceuticals and Healthcare Company Profile, SWOT & Financial Report" is a crucial resource for industry executives and anyone looking to access key information about "UnitedHealth Group Incorporated" ICD Research's "UnitedHealth Group Incorporated: Pharmaceuticals and Healthcare Company Profile, SWOT & Financial Report" report utilizes a wide range of primary and secondary sources, which are analyzed and presented in a consistent and easily accessible format. ICD Research strictly follows a standardized research methodology to ensure high levels of data quality and these characteristics guarantee a unique report. Buy online from $125