ber 2008 Transcept submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of Intermezzo
® as a prescription sleep aid for use in the middle of the night at the time a patient awakens and has difficulty returning to sleep. In October 2009 Transcept received a Complete Response Letter from the FDA on the Intermezzo
® NDA and is working to respond to issues raised in the letter. Transcept and Purdue Pharmaceutical Products, L.P. have entered into a collaboration agreement for the development and commercialization of Intermezzo
® in the United States. For further information, please visit the company's website at: www.transcept.com.
The United States Patent and Trademark Office granted a Notice of Allowance for claims that cover Intermezzo® under U.S. patent application no. 11/833,323. If issued, this patent will expire in 2025. Transcept is actively pursuing additional patents to protect Intermezzo® in the United States and key non-U.S. markets, and, as part of the NDA submission, has requested that the FDA grant three years of Hatch-Waxman marketing exclusivity to Intermezzo®.
Transcept Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of proprietary products that address important therapeutic needs in neuroscience. For further information, please visit the company's website at: www.transcept.com.
Forward Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding our strategy, future operations, future financial position, future revenues, projected expenses, prospects, plans and objectives of man
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