Watson Receives FDA Response on Cancer Drug

Watson Pharmaceuticals has received a Complete Response Letter from the US Food and Drug Administration (FDA) on its New Drug Application (NDA) for Trelstar 22.5 mg (triptorelin pamoate for injectable suspension), a 24-week formulation for the palliative treatment of advanced prostate cancer. The NDA was prepared in cooperation with Debiopharm Group.

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.