Events Details
Aurobindo Pharma receives USFDA Approval for Glycerol Phenylbutyrate Oral Liquid, 1.1 grams per mL
Monday, April 20, 2026
Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration to manufacture and market Glycerol Phenylbutyrate Oral Liquid, 1.1 g/mL. This product is equivalent to the reference drug Ravicti by Horizon Therapeutics.
The product will be manufactured at the company’s Unit-III facility and is expected to be launched immediately.
According to IQVIA data, the product has an estimated market size of about $50.2 million for the 12 months ending February 2026. With this approval, Aurobindo Pharma now has a total of 579 ANDA approvals from the USFDA, including 556 final approvals and 23 tentative approvals.
Glycerol Phenylbutyrate Oral Liquid is used to treat patients with Urea Cycle Disorders (UCDs). It works as a nitrogen-binding agent and is prescribed for long-term management in patients who cannot be treated with diet changes or amino acid supplements alone.
Source: aurobindo.com
