Abbott announced that the FDA has approved Lupron Depot-PED (leuprolide acetate for depot suspension) 11.25mg and 30mg for three-month administration for the treatment of children with central precocious puberty (CPP). The approval of the new three-month formulations was based on data from a 24-week, open-label study involving 84 patients with CPP. Patients received a total of two injections, 12 weeks apart, and were followed for nearly six months to evaluate hormone suppression and safety. Overall, hormone suppression with the three-month depot formulation in both strengths was sustained in patients throughout the treatment period. In patients who had not been previously treated for CPP, the onset of hormone suppression was consistent with other currently available Lupron Depot-PED formulations.
Lupron Depot-PED is already available in a one-month formulation in 7.5mg, 11.25mg, and 15mg dosage strengths. Lupron Depot-Ped 3-month is expected to be available in late August 2011.
For more information call (800) 633-9110 or visit www.lupronped.com.