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In Brief: TAP's Lupron Depot

Executive Summary

TAP's Lupron Depot: Leuprolide acetate for depot suspension approved Dec. 22 in a three-month 22.5 mg dosage form for the palliative treatment of advanced prostatic cancer. Lupron Depot was available previously for prostate cancer in a once-monthly 7.5 mg dose. TAP filed the NDA (20-517) for the three-month (84-day) formulation in December 1994. The company has committed to Phase IV studies of three-month Lupron Depot that include a one-year pharmacokinetic/pharmacodynamic study of multiple doses and a six-month study comparing once-monthly Lupron Depot to the three-month product with regard to stimulation of gonadotropin secretion upon reinjection...
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