2 new strengths of leuprolide acetate

FDA has approved 2 new strengths (11.25 mg and 30 mg) for 3-month administration of leuprolide acetate for depot suspension (Lupron Depot-PED, Abbott) for the treatment of children with central precocious puberty (CPP).

CPP is a condition that causes children to enter puberty too soon, resulting in the development and progression of secondary sex characteristics such as breast development in females and genital development in both males and females, and can potentially lead to a diminished adult height. By definition, CPP appears in girls under 8 years of age and boys under 9 years of age. Treatment with Lupron Depot-PED helps to arrest pubertal development until a more appropriate time.

“The approval of 2 new 3-month depot strengths of Lupron Depot-PED is important because it adds additional treatment options for children with CPP and may reduce the number of injections per year from 12 to 4,” said Eugene Sun, MD, vice president, Global Pharmaceutical Development, Abbott.

Patients with central precocious puberty who have been prescribed Lupron Depot-PED receive an injection that is administered in the physician’s office. The 3 current strengths of Lupron Depot-PED are given to patients once a month. Now, patients who are prescribed the newly approved formulation may receive their treatments every 3 months.