USFDA5 May 2026, 09:09 am
Lupin Gets U.S. FDA Nod for Glycerol Phenylbutyrate Oral Liquid
AI Summary
Lupin Ltd. has received U.S. FDA approval for its Abbreviated New Drug Application for Glycerol Phenylbutyrate Oral Liquid, 1.1 grams per mL, bioequivalent to Ravicti® Oral Liquid of Horizon Therapeutics. It is indicated for chronic management of urea cycle disorders (UCDs). The product sales for Glycerol Phenylbutyrate Oral Liquid (RLD Ravicti®) were USD 337 million for the year ended December 2025.
Key Highlights
- Lupin receives U.S. FDA approval for Glycerol Phenylbutyrate Oral Liquid.
- The drug is bioequivalent to Horizon Therapeutics' Ravicti® Oral Liquid.
- It is used for managing urea cycle disorders (UCDs).
- Ravicti® had sales of USD 337 million in 2025.