# FDA Approves Haleon's Orlistat (Alli) for Over-the-Counter Weight Management Haleon US Holdings LLC received FDA approval for Alli (orlistat), marking the first nonprescription weight-loss medication available in the U.S. and potentially expanding the over-the-counter pharmaceuticals market to include obesity management. The oral formulation is expected to capture significant market share in the $2+ billion weight management category as consumers gain access to a clinically proven alternative to prescription options.