Aurobindo Pharma bags USFDA nod for Glycerol Phenylbutyrate Oral Liquid

The approved product is a generic version of Ravicti, originally developed and marketed by Horizon Therapeutics

Aurobindo Pharma has received approval from the US Food and Drug Administration for its Glycerol Phenylbutyrate Oral Liquid, strengthening its portfolio in the niche metabolic disorder segment in the United States.

Glycerol Phenylbutyrate Oral Liquid is indicated for the chronic management of certain rare conditions known as urea cycle disorders (UCDs), where the body cannot effectively remove ammonia from the bloodstream. Elevated ammonia levels can lead to serious neurological complications, making long-term treatment critical.

The approved product is a generic version of Ravicti, originally developed and marketed by Horizon Therapeutics. The drug is typically prescribed for adult and pediatric patients as a maintenance therapy to control ammonia levels alongside dietary management.

Industry analysts note that the approval is strategically significant for Aurobindo, given the limited competition and high entry barriers in the rare disease segment. The company’s move aligns with its broader strategy to expand into complex generics and specialty products in regulated markets.

With this approval, Aurobindo continues to deepen its presence in the US generics market, leveraging its manufacturing and regulatory capabilities to tap into high-value therapeutic areas.