FDA OKs Aurobindo's generic Actigall

Aurobindo has received the green light from the Food and Drug Administration for ursodiol capsules, 300 mg, which are the generic of Teva’s Actigall.

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; and for the prevention of gallstone formation in obese patients experiencing rapid weight loss.

[Read more: Aurobindo obtains FDA approval for generic Colcrys]

Ursodiol capsules have a market value of roughly $35.7 million for the 12 months ending September 2022, according to IQVIA.