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Global pharma major Lupin Limited (Lupin) announced that it has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Applications for glycerol phenylbutyrate oral liquid, 1.1 grams per mL.
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 US Holding LLC. It is indicated for chronic management of patients with urea cycle disorders (UCDs) that cannot be managed by dietary protein restriction and/or amino acid supplementation alone.
The product sales for glycerol phenylbutyrate oral liquid (Ravicti) were USD 337 million for the year ended December 2025. (IQVIA MAT DEC 2025).
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