FDA accepts new drug application for advanced prostate cancer therapy

December 4, 2008

The FDA has accepted the new drug application for a 6-month formulation of triptorelin pamoate (Trelstar), a luteinizing hormone releasing hormone agonist for the palliative treatment of advanced prostate cancer, according to Watson Pharmaceuticals, the drug's manufacturer.

The FDA has accepted the new drug application for a 6-month formulation of triptorelin pamoate (Trelstar), a luteinizing hormone releasing hormone agonist for the palliative treatment of advanced prostate cancer, according to Watson Pharmaceuticals, the drug’s manufacturer.

The sustained-release formulation of triptorelin pamoate is designed to suppress the production of testosterone in men with advanced prostate cancer over 6 months.

“This new, longer duration Trelstar formulation requires only one injection every 24 weeks and showed comparable efficacy and safety with our marketed 1- and 3-month formulations,” said Paul Bisaro, Watson’s president and CEO.