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FDA approves two strengths of a new leuprolide acetate formulation
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Two strengths of leuprolide acetate for depot suspension in a 3-month formulation have been approved by the FDA for treatment of central precocious puberty.
Leuprolide acetate for depot suspension (Lupron Depot-PED, Abbott) is currently available as a 7.5-mg, 11.25-mg or 15-mg once-monthly injection for children diagnosed with central precocious puberty. The FDA’s decision now allows the drug to be administered in an 11.25-mg or 30-mg dose every 3 months.
The manufacturer’s submission for approval was based on data from a 24-week, open-label study involving 84 patients with central precocious puberty. Patients received two injections, administered 12 weeks apart, and were followed for nearly 6 months to evaluate hormone suppression and safety. Results indicated that hormone suppression with both strengths of the 3-month depot formulation was sustained throughout the treatment period. In previously untreated patients, the onset of hormone suppression was consistent with other currently available formulations of the drug. The most commonly reported side effects were injection-site pain, weight gain, headache, altered mood and injection-site swelling. Other adverse reactions included acne; rash with or without fever, blisters or sores, and facial swelling; and vaginitis, vaginal bleeding or vaginal discharge.
“The approval of two new 3-month depot strengths of Lupron Depot-PED is important because it adds additional treatment options for children with [central precocious puberty] and may reduce the number of injections per year from 12 to four,” Eugene Sun, MD, vice president of global pharmaceutical development at Abbott, said in a press release.
The new formulation is expected to be available in late August.
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