FDA Approves Tivorbex

FDA has approved Iroko Pharmaceuticals’ Tivorbex (indomethacin), a low-dose painkiller for adult patients. The drug is a nonsteroidal anti-inflammatory drug approved at 20-mg and 40-mg doses for the treatment of mild to moderate acute pain. It contains indomethacin as submicron particles that are approximately 20 times smaller than their original size, providing an increased surface area, leading to faster dissolution. The approval follows FDA’s OK of Iroko’s Zorvolex (diclofenac) capsules, developed using the same technology, for the treatment of mild-to-moderate acute pain in adults.