GlaxoSmithKline (GSK) and XenoPort has reported that the FDA has extended the original Prescription Drug User Fee Act (PDUFA) goal date for its review of the New Drug Application (NDA) for GSK1838262/XP13512 (gabapentin enacarbil) November 9, 2009. The company said that the original PDUFA date for the NDA review was November 9, 2009.
Earlier, the FDA determined that a Risk Evaluation and Mitigation Strategy (REMS) was necessary for GSK1838262. In response to FDA’s request, GSK submitted a proposed REMS.
Reportedly, the FDA has accepted the submission as a solicited major amendment to the GSK1838262 NDA. The FDA has the option to extend the PDUFA goal date when a sponsor submits a major amendment that provides a substantial amount of new data not previously reviewed by the FDA.