East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Ursodiol Capsules USP, 300mg. Aurobindo Pharma’s Ursodiol Capsules, are an AB-rated generic equivalent to the reference listed drug (RLD), Actigall® Capsules, manufactured by Teva Branded Pharmaceutical Products R&D, Inc.

Ursodiol Capsules are indicated for:

• Patients with radiolucent, noncalcified gallbladder stones <20mm in greatest diameter in whom elective cholecystectomy would be undertaken except for the presence of increased surgical risk due to systemic disease, advanced age, idiosyncratic reaction to general anesthesia, or for those patients who refuse surgery.
• The prevention of gallstone formation in obese patients experiencing rapid weight loss.