Lupin Limited Receives U.S. FDA Approval for Glycerol Phenylbutyrate Oral Liquid
Mumbai, India, Naples, Fla, May 5, 2026: Global pharmaceutical major Lupin Limited today announced that it has secured approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Applications (ANDAs) concerning Glycerol Phenylbutyrate Oral Liquid, 1.1 grams per mL.This newly approved product, 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, manufactured by Horizon Therapeutics U.S. Holding LLC. The drug is indicated for the chronic management of patients dealing with urea cycle disorders (UCDs) that cannot be managed...