FDA Approves Second Indication For Iroko Pharma’s NSAID Zorvolex

Iroko Pharmaceuticals LLC Aug. 25 announced that the Food and Drug Administration has approved Zorvolex (diclofenac) capsules, a nonsteroidal anti-inflammatory drug (NSAID), for managing osteoarthritis pain.

This marks the second indication for Zorvolex. The FDA approved the drug in October 2013 for treating mild to moderate acute pain in adults 11 PLIR 1288, 10/25/13.

Zorvolex was developed to align with recommendations from the FDA and several professional medical organizations that NSAIDs be used at the lowest effective dose for the shortest possible duration consistent with individual patient treatment goals, the company said. Zorvolex is the first FDA-approved low- dose ...