Shots:

• The approval is based on P-III study which involves assessing of leuprolide acetate (LA-45 mg) in 64 children with central (gonadotropin-dependent) precocious puberty evaluating its safety and pharmacokinetics
• The study achieved its 1E i.e. 87% of children achieved a serum luteinizing hormone concentration of <4 IU/L at six months post injection with most common TEAEs were injection site pain (31%)- nasopharyngitis (22%)- and fever (17%)
• Fensolvi (leuprolide acetate) is a novel six-month- subcutaneous leuprolide acetate an gonadotropin releasing hormone (GnRH) agonist with small injectable suspension pproved for the treatment of pediatric patients two years of age and older with Central Precocious Puberty

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