Lupin Gets U.S. FDA Approval for Glycerol Phenylbutyrate Oral Liquid
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Lupin gets U.S. FDA approval for Glycerol Phenylbutyrate Oral Liquid
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…
Lupin receives US FDA approval for Glycerol Phenylbutyrate oral liquid
Global pharma major Lupin 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. 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 p…
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