Lupin's US subsidiary Lupin Pharmaceuticals, Inc. has received tentative approval for its diclofenac capsules USP, 18 mg and 35 mg from the US FDA to market a generic version of Zorvolex capsules.
Lupin’s diclofenac capsules USP, 18 mg and 35 mg are the AB rated generic equivalent of Iroko Pharmaceuticals LLC's Zorvolex capsules 18 mg and 35 mg. It is indicated for management of mild to moderate acute pain and management of osteoarthritis pain.
Zorvolex capsules had US sales of USD 39.6 million (IMS MAT September 2016).