Lupin’s generic for UCDs gets U.S. FDA nod

Generic drugmaker Lupin has received U.S. Food and Drug Administration (U.S. FDA) support for its abbreviated caller cause applications for Glycerol Phenylbutyrate Oral Liquid, 1.1 grams per mL.

The merchandise is bioequivalent to notation listed cause Ravicti Oral Liquid, 1.1 grams per mL, of Horizon Therapeutics U.S. Holding LLC. It is indicated for chronic absorption of patients with urea rhythm disorders (UCDs) that cannot beryllium managed by dietary macromolecule regularisation and/or amino acerb supplementation alone.