FDA approves New Drug Application for 6-month subcutaneous depot formulation of leuprolide mesylate (Camcevi 42 mg) as a treatment of advanced prostate cancer

Approval was based on phase 3 study (n=137) which reported that the primary efficacy endpoint was successfully achieved in 97% of subjects, with mean testosterone concentration suppressed below castrate levels to 17.6 ng/dL on day 28.

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