Tivorbex (indomethacin); Iroko Pharmaceuticals; For the treatment of acute pain,

New Drug Approvals

Indometacin skeletal.svg

Tivorbex (indomethacin); Iroko Pharmaceuticals; For the treatment of acute pain, Approved February of 2014

2-{1-[(4-chlorophenyl)carbonyl]-5-methoxy-2-methyl-1H-indol-3-yl}acetic acid

cas 53-86-1

PHILADELPHIA—Iroko Pharmaceuticals, LLC, a global specialty pharmaceutical company dedicated to advancing the science of analgesia, today announced that the U.S. Food and Drug Administration (FDA) has approved TIVORBEX™ (indomethacin) capsules, a nonsteroidal anti-inflammatory drug (NSAID), at 20 mg and 40 mg doses for the treatment of mild to moderate acute pain in adults1.

“TIVORBEX is the second NSAID to be approved from Iroko’s lower dose NSAID pipeline that uses proprietary SoluMatrix Fine Particle Technology™.”

TIVORBEX was approved at dosage strengths that are 20 percent lower than the 25 mg and 50 mg indomethacin products currently on the market2. FDA approval of TIVORBEX was supported by data from two Phase 3 multi-center, placebo-controlled trials that demonstrated significant improvement in pain relief in patients with post-surgical acute pain receiving TIVORBEX compared with…

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