MORRISTOWN, N.J. The Food and Drug Administration has rejected an application from Watson Pharmaceuticals for a new formulation of a prostate cancer drug.
Watson announced Tuesday that the FDA had given it a complete response letter for its approval application for a 24-week formulation of Trelstar (triptorelin pamoate for injectable suspension) in the 22.5-mg strength. Watson had prepared the application with Swiss biotech company Debiopharm Group.
The FDA asked Watson for additional clinical testing data, third-party manufacturing data and data related to chemistry, manufacturing and controls. Watson said it was working to provide the agency with the information requested.