Aurobindo Pharma announced the receipt of the final approval from the US Food & Drug Administration (USFDA) to manufacture and market Glycerol Phenylbutyrate Oral Liquid, 1.1 grams per mL, which is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Ravicti Oral Liquid 1.1 grams per mL, of Horizon Therapeutics U.S. Holding LLC.
The product will be manufactured by Unit-III of the Company and will be launched immediately.
The approved product has an estimated market size of US$ 50.2 million for the twelve months ending February 2026, according to IQVIA MAT. Aurobindo Pharma now has a total of 579 ANDA approvals (556 final approvals and 23 tentative approvals) from USFDA.
Glycerol Phenylbutyrate Oral Liquid is 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.