GlaxoSmithKline (GSK) and XenoPort, Inc. (XNPT) said on Friday that the U.S. Food and Drug Administration, or FDA, has extended the original Prescription Drug User Fee Act, or PDUFA, goal date for its review of the New Drug Application for GSK1838262/XP13512, gabapentin enacarbil, to February 9, 2010. The original PDUFA date for this NDA review was November 9, 2009.
The FDA determined that a Risk Evaluation and Mitigation Strategy, or REMS, was necessary for GSK1838262. In response to FDA's request, GSK submitted a proposed REMS. The FDA accepted this 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.
For comments and feedback contact: editorial@rttnews.com
June 05, 2026 16:18 ET A busy week for economic news flow saw a slew of reports being released that reflected the trends in the U.S. labor market. In Europe, economic growth and inflation data gained attention as the European Central Bank and Bank of England head for policy session later in the month. In Asia, the monetary policy session of the Indian central bank was in focus as the country, a major oil importer, reels under the pressures of a weaker rupee and rising inflation.