NDA resubmitted for Intermezzo for insomnia - ONA
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NDA resubmitted for Intermezzo for insomnia - ONA
View full resource at oncologynurseadvisor.com
Tags: Sleep Disorder, Insomnia, Insomnia Medication, Drug, Pharma, FDA, Ambien
Most Recently Shared on January 19, 2011 at 7:19 pm By:
NDA resubmitted for Intermezzo for insomnia http://goo.gl/fb/Cwbsn
Transcept decreases workforce to reduce expenses following FDA news on Intermezzo NDA
news-medical.net — “Transcept Pharmaceuticals, Inc. announced today plans to reduce operating expenses by eliminating approximately 45% of its workforce following notification from the U.S. Food and Drug Administration (FDA) that the resubmitted New Drug Application (NDA) for Intermezzo, the company's lead product candidate, cannot be approved in its present form.” View full resource at news-medical.net
Most Recently Shared on July 16, 2011 at 12:07 pm By:
Transcept decreases workforce to reduce expenses following FDA news on Intermezzo NDA: Transcept Pharmaceuticals... http://bit.ly/q8UJi6
Transcept Pharmaceuticals Receives Complete Response Letter From FDA On Intermezzo® New Drug Application - QualityPoint Technologies
qualitypointtech.net — “Transcept Pharmaceuticals, Inc. (Nasdaq: TSPT) announced that it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) regarding the resubmitted New Drug Application (NDA) for Intermezzo® (zolpidem tartrate sublingual tablet). In the Complete Response Letter, the FDA confirmed that Transcept has adequately demonstrated that Intermezzo® is efficacious for use as needed in the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty re” View full resource at qualitypointtech.net
Most Recently Shared on July 16, 2011 at 11:00 am By:
Transcept Pharmaceuticals Receives Complete Response Letter From FDA On Intermezzo® New Drug Application: Transce... http://bit.ly/qyPmeA
NDA resubmitted for Intermezzo for insomnia - MPR
empr.com — “Transcept Pharmaceuticals announced that it has resubmitted its New Drug Application (NDA) to the FDA seeking approval of Intermezzo (zolpidem tartrate sublingual tablet) for use as needed for the treatment of insomnia when a middle of the night awakening is followed by difficulty returning to sleep.” View full resource at empr.com
Most Recently Shared on January 19, 2011 at 7:57 pm By:
MPR News: NDA resubmitted for Intermezzo for insomnia: Transcept Pharmaceuticals announced that it has resubmitt... http://bit.ly/gsEf0t
UPDATE 1-Transcept to try again with sleep-disorder drug | Reuters
reuters.com — “* Plans to resubmit NDA in Q1 2011 * Follows highway driving study * Sees a six-month review by the FDA Oct 19 (Reuters) - Transcept Pharmaceuticals Inc plans to resubmit a new” View full resource at reuters.com
Most Recently Shared on October 19, 2010 at 10:48 am By:
John Carroll Health Communicator
Here's the Reuters story on Transcept's Intermezzo. http://www.reuters.com/article/idUSSGE69I08820101019
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