East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Glycerol Phenylbutyrate Oral Liquid, 1.1 grams per mL. Aurobindo Pharma’s Glycerol Phenylbutyrate Oral Liquid, are an AB-rated generic equivalent to the reference listed drug (RLD), Ravicti Oral Liquid, manufactured by Horizon Therapeutics U.S. Holding LLC.

Glycerol Phenylbutyrate Oral Liquid are indicated for use:

• As a nitrogen-binding agent for chronic management of patients with urea cycle disorders (UCDs) who cannot be managed by dietary protein restriction and/or amino acid supplementation alone.