FDA to review Iroko's Tiforbex

Iroko Pharmaceuticals LLC (Philadelphia, Pa.) said FDA accepted for review an NDA for Tiforbex submicron indomethacin to treat mild to moderate acute pain in adults. The company submitted the application in April; a standard 10-month review would place the PDUFA date in February 2014, though a specific date is not disclosed. Tiforbex is a nanoformulation of the NSAID indomethacin using Iroko's SoluMatrix nanoformulation technology. ...