FDA Approves GLYCEROL PHENYLBUTYRATE — Novadoz Pharmaceuticals LLC

# FDA Approves Novadoz Pharmaceuticals' Generic Glycerol Phenylbutyrate Oral Formulation Novadoz Pharmaceuticals LLC has received FDA approval for its generic oral formulation of glycerol phenylbutyrate (ANDA219540), marking a significant entry into the urea cycle disorder treatment market that is expected to increase price competition and expand patient access. The approval positions Novadoz to capture market share in the therapeutic category while potentially reducing treatment costs for patients managing this rare metabolic disorder.