MUMBAI, India and NAPLES, Fla. — Global pharmaceutical leader Lupin Limited today announced that it has received approval from the United States Food and Drug Administration for its Abbreviated New Drug Applications for Glycerol Phenylbutyrate Oral Liquid, 1.1 grams per mL, for the chronic management of patients with urea cycle disorders (UCDs) who cannot be managed solely by dietary protein restriction and/or amino acid supplementation.
Glycerol Phenylbutyrate Oral Liquid, 1.1 grams per mL, is bioequivalent to the reference listed drug (RLD), Ravicti® Oral Liquid, 1.1 grams per mL, of Horizon Therapeutics U.S. Holding LLC. It is indicated for the chronic management of patients with urea cycle disorders (UCDs) who cannot be managed solely by dietary protein restriction and/or amino acid supplementation.
Product sales for Glycerol Phenylbutyrate Oral Liquid (RLD Ravicti®) totaled USD 337 million for the year ended December 2025.
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