India, April 17 -- Aurobindo Pharma Limited has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Glycerol Phenylbutyrate Oral Liquid, 1.1 gm/mL.
The product is therapeutically equivalent to the reference drug Ravicti Oral Liquid by Horizon Therapeutics and will be produced at the company's Unit-III facility, with launch planned immediately.
According to IQVIA data, the drug has an estimated US market size of $50.2 million for the 12 months ending February 2026. With this, Aurobindo Pharma's total USFDA approvals have reached 579, including 556 final approvals and 23 tentative approvals.
The medication is used for the chronic management of patients with urea cycle disorders, particularly t...