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news.FDA has requested additional information on CMC and third party manufacturing
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Watson Pharmaceuticals has received a Complete Response Letter from FDA on its New Drug Application (NDA) for Trelstar 22.5mg (triptorelin pamoate for injectable suspension). Its a 24-week formulation of TRELSTAR for the palliative treatment of advanced prostate cancer.
According to the letter, 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. The authority has also requested information related to third party manufacturing. Watson is working to ensure that the requested information is provided to the FDA expeditiously.
The new, longer-acting formulation of Trelstar is designed to be suitably administered and to continuously suppress the production of testosterone in men with advanced prostate cancer for 24 weeks.