Iroko Pharma gains FDA approval for low-dose indomethacin drug Tivorbex

US specialty drugmaker Iroko Pharmaceuticals has received approval from the US Food and Drug has approved Tivorbex (indomethacin) capsules, a non-steroidal anti-inflammatory drug (NSAID), at 20mg and 40mg doses for the treatment of mild to moderate acute pain in adults.

Tivorbex was approved at dosage strengths that are 20% lower than the 25mg and 50mg indomethacin products currently on the market. FDA approval of Tivorbex was supported by data from two Phase III multicenter, placebo-controlled trials that demonstrated significant improvement in pain relief in patients with post-surgical acute pain receiving Tivorbex compared with those given placebo.

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