Abbott announced that the FDA has approved a 45mg for six-month administration formulation of Lupron Depot (leuprolide acetate for depot suspension) for the palliative treatment of advanced prostate cancer. This approval was based on data from a 48-week, open-label study involving 151 patients with prostate cancer. Patients received a total of two injections, 24 weeks apart, and were followed for nearly one year to evaluate testosterone suppression and safety. Overall, testosterone suppression with the 45mg six-month depot formulation was sustained in patients throughout the treatment period. The onset of testosterone suppression was consistent with other currently available Lupron Depot formulations.
Lupron Depot 6-Month 45mg is expected to be available in late June 2011. Lupron Depot is already available for the palliative treatment of prostate cancer as Lupron Depot 7.5mg, Lupron Depot 3-month 22.5mg, and Lupron Depot 4-Month 30mg injections.
For more information call (800) 621-1020 or visit www.prostate.com.