Tolmar Pharmaceuticals Receives FDA Approval

FDA Approves FENSOLVI® (leuprolide acetate) for Injectable Suspension for Pediatric Patients with Central Precocious Puberty

  • Fensolvi is the only six-month, subcutaneously administered leuprolide acetate approved for the treatment of pediatric patients two years of age and older with Central Precocious Puberty
  • FDA approval was based on data from a multicenter, open-label, single-arm Phase 3 study with twice-yearly dosing
  • Fensolvi demonstrated clinical efficacy in suppressing sex hormone levels and arresting or reversing progression of puberty with a favorable safety and tolerability profile

Find out more.

Categories: Ecosystem News