On Tuesday July 12, 2011, Transcept Pharmaceuticals, Inc. (NASDAQ:TSPT) announced that it expects to get a Complete Response Letter from the U.S. Food and Drug Administration (FDA) in relation to the resubmitted New Drug Application (NDA) for Intermezzo® (zolpidem tartrate sublingual tablet) on or prior to Thursday, July 14, 2011, which is the PDUFA date assigned by the FDA for completion of the Intermezzo® NDA review.
The FDA issues a Complete Response Letter as an indication of the completion of a review cycle for an NDA and means that the application is not ready for approval.
TheIntermezzo® NDA looks forward for the approval to market Intermezzo® for use as needed for the treatment of insomnia which is the problem of returning to sleep when awakened at the middle of the night.
This update from Transcept is based on a teleconference with the FDA held earlier today during which the FDA expressed continued concerns about the safety profile of Intermezzo® based on information in the resubmitted NDA. Until Transcept receives the anticipated Complete Response Letter, the company has limited information as to the full extent of FDA concerns. After the Complete Response Letter is received, Transcept will announce additional information on the content of the letter and the company’s plans for the future regulatory development of Intermezzo®.
Transcept Pharmaceuticals, Inc., formerly Novacea, Inc., is a specialty pharmaceutical company focused on the development and commercialization of products that address important therapeutic needs in neuroscience.
At 2:59 PM EDT, on Wednesday, the shares of the Company were priced at $5.05 after rising 41.21% and trading in the range of $4.89 – $5.36, creating a 52-Week lowest at such low. The market cap of the Company amounted to 68.88 million.
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