Posted 8/29/2012 1:45 PM (GMT 0)
Johnson & Johnson Prostate Cancer Drug Gets FDA Priority Review Status
Published August 29, 2012
Johnson & Johnson's (JNJ) Janssen unit said the U.S. Food and Drug Administration granted priority review status to its application for Zytiga in combination with another drug for men with prostate cancer who haven't undergone chemotherapy.
The company submitted its new drug application for Zytiga in combination with the anti-inflammatory drug prednisone during June. The FDA usually grants the expedited review process, estimated at about six months, for drugs that offer major advances in treatment or provide treatment where no current therapy exists.
Zytiga was approved by U.S. regulators last year to be used in combination with the drug prednisone to treat men with advanced prostate cancer who have previously tried a chemotherapy.
Read more: http://www.foxbusiness.com/news/2012/08/29/johnson-johnson-prostate-cancer-drug-gets-fda-priority-review-status/print#ixzz24wUqYRLJ