FDA approves Iroko Pharmaceuticals NSAID

PHILADELPHIA — The Food and Drug Administration has approved a pain drug made by Iroko Pharmaceuticals, Iroko said.

The drug maker announced the approval of Zorvolex (diclofenac) capsules for mild to moderate acute pain in adults. The drug is a non-steroidal anti-inflammatory drug, or NSAID, belonging to the same class as the common analgesic drug ibuprofen. Zorvolex was approved at dosage strengths 20% lower than currently available diclofenac products, the company said.

"The approval of Zorvolex is important news for patients and for physicians who need new options for effective pain relief and is a significant milestone for Iroko," Iroko president and CEO John Vavricka said. "This marks a major achievement toward our goal of applying new technology to existing NSAIDs in order to address unmet medical needs in analgesia."