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FDA Requests Additional Information for Triptorelin Pamoate Submission
According to the letter, the FDA has requested clarifications related to the clinical testing of the product, additional information regarding the chemistry, manufacturing and controls (CMC) of the product and other components, and information related to third party manufacturing. Watson is working to ensure the requested information is provided to the FDA expeditiously.
TRELSTAR® 22.5 mg builds on Watson's long-standing track record in prostate cancer and expanding urology franchise. The new, longer-acting formulation of TRELSTAR® is designed to be conveniently administered and to continuously suppress the production of testosterone in men with advanced prostate cancer for 24 weeks. TRELSTAR® is an already proven therapy with established efficacy and safety in two formulations - a four-week formulation (TRELSTAR® DEPOT) and a 12-week formulation (TRELSTAR® LA).
TRELSTAR®, developed by Debiopharm Group and marketed by Watson, administers a synthetic luteinizing hormone releasing hormone (LHRH) agonist, triptorelin, which suppresses the production of testosterone in the testicles. Prostatic cancer proliferation is regulated in part by the level and activity of testosterone. TRELSTAR® is currently available in a four-week depot formulation (TRELSTAR® DEPOT) and a 12-week long-acting formulation (TRELSTAR® LA), offering an alternative treatment for prostate cancer when orchiectomy (removal of the testicles) or estrogen administration are either not indicated or unacceptable to the patient. TRELSTAR® does not require refrigeration and should be stored at controlled room temperature.
Source: Watson Pharmaceuticals