Transcept Pharmaceuticals Inc. (TSPT) said that the U.S. FDA has set July 14, 2011 as the PDUFA action date for its Intermezzo.
Intermezzo is indicated for use as needed for the treatment of insomnia when a middle of the night awakening is followed by difficulty returning to sleep.
The company's application for Intermezzo was already rejected by the FDA in October, 2010, requesting additional data demonstrating that Intermezzo, when taken as directed in the middle of the night, would not present an unacceptable risk of residual effects, with particular reference to next day driving ability.
Earlier this month, the company resubmitted its application, which is now classified by the FDA as a complete Class 2 response, and assigned a PDUFA action date of July 14, 2011.
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.