Tolmar Pharmaceuticals Receives FDA Approval
By: Colorado BioScience Association Date: 05/05/2020
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.