NDA Accepted for Six-Month Prostate Cancer Treatment

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NDA Accepted for Six-Month Prostate Cancer Treatment
William WeberJanuary 22, 2009

Prostate Cancer
The New Drug Application (NDA) by Watson Pharmaceuticals, Inc., for a six-month formulation of Trelstar (triptorelin pamoate) has been accepted for filing. Triptorelin is a luteinizing hormone-releasing hormone (LHRH) agonist for the palliative treatment of advanced prostate cancer. The sustained-release formulation of the drug is designed to suppress testosterone production over a six-month period. “This Trelstar formulation requires only one injection every 24 weeks and showed comparable efficacy and safety with our marketed Trelstar one- and three-month formulations,” said Paul Bisaro, Watson's president and chief executive officer. “It should be a welcome alternative for men and their physicians and will be a significant addition to our expanding urology portfolio.” The company expects the FDA to take action on the NDA in the third quarter of 2009.


From the January 2009 Issue of Renal And Urology News