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Watson Announces the NDA for a 6-Month Formulation of TRELSTAR(R) Accepted for Filing by FDA for the Treatment of Advanced Prostate Cancer
Date:11/13/2008

CORONA, Calif., Nov. 13 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI), a leading specialty pharmaceutical company, today announced that its New Drug Application (NDA) for a 6-month formulation of TRELSTAR(R) (triptorelin pamoate), a luteinizing hormone releasing hormone (LHRH) agonist, has been accepted for filing by the U.S. Food and Drug Administration (FDA). Watson is seeking marketing approval of this TRELSTAR(R) 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(R) is designed to suppress the production of testosterone in men with advanced prostate cancer over 6 months. Prostate cancer growth is regulated in part by the level and activity of testosterone.

"This filing reflects Watson's commitment to urology and to making a difference in the lives of men living with prostate cancer," said Paul Bisaro, Watson's President and Chief Executive Officer. "This new longer duration TRELSTAR(R) formulation requires only one injection every 24 weeks, and showed comparable efficacy and safety with our marketed TRELSTAR(R) 1 and 3-month formulations. The TRELSTAR(R) 6-month formulation should be a welcome alternative for men and their physicians and will be a significant addition to our expanding urology portfolio."

About TRELSTAR(R)

TRELSTAR(R), developed by Debiopharm Group, a Swiss biopharmaceutical development specialist, and marketed by Watson Pharma, Inc., is a synthetic hormone known as a luteinizing hormone releasing hormone (LHRH) agonist, which suppresses the production of testosterone in the testicles. The growth of the prostate is reg
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SOURCE Watson Pharmaceuticals, Inc.
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