FDA accepts Watson’s NDA for filing
- Posted on 20 November 2008
Watson says the new drug application for a six-month formulation of Trelstar has been accepted for filing by the FDA for the treatment of advanced prostate cancer.
Trelstar (triptorelin pamoate) is a luteinizing hormone releasing hormone (LHRH) agonist and Watson is seeking marketing approval of this formulation for the palliative treatment of advanced prostate cancer.
Watson anticipates that FDA will take action on its application in the third quarter 2009.
The company says the sustained-release formulation of Trelstar is designed to suppress the production of testosterone in men with advanced prostate cancer over six months.
Prostate cancer growth is regulated in part by the level and activity of testosterone.
