FDA Accepts New Drug Application For Priority Review Of Investigational HIV Treatment TMC125

Tibotec Pharmaceuticals Ltd. announced that the New Drug Application (NDA) for TMC125 (etravirine), an investigational non nucleoside reverse transcriptase inhibitor (NNRTI), has been accepted for priority review by the United States Food and Drug Administration (FDA). The Prescription Drug User Fee Act (PDUFA) user fee goal date for the NDA for TMC125, the date by which the FDA must announce its decision regarding the application, will be January 18, 2008. [click link for full article]

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Filed under: HIV / AIDS on September 21st, 2007