Watson is seeking marketing approval of the Trelstar 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 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.
Paul Bisaro, president and CEO of Watson, said: “This filing reflects Watson’s commitment to urology and to making a difference in the lives of men living with prostate cancer. This new longer duration Trelstar formulation requires only one injection every 24 weeks, and showed comparable efficacy and safety with our marketed Trelstar one and three-month formulations.”