FDA extends review of NDA for Entereg® (alvimopan)
The NDA for Entereg 12 mg capsules is for in-hospital, short-term use for the management of postoperative ileus (POI). Specifically, the proposed indication
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http://www.gsk.com/media/pressreleases/2008/2008_us_pressrel...
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FDA Approves Entereg to Help Restore Bowel Function Following Surgery
20 May 2008 ... The US Food and Drug Administration approved Entereg (alvimopan) today to accelerate the restoration of normal bowel function in patients 18 ...
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/20...
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GlaxoSmithKline and Adolor update alvimopan (Entereg/Entrareg ...
11 Jun 2007 ... GlaxoSmithKline and Adolor Corporation today provided an update on the alvimopan (Entereg/Entrareg®) development programme. ...
http://www.gsk.com/media/pressreleases/2007/2007_06_11_GSK10...
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NDA 21-775 ENTEREG® (alvimopan) REMS October 6, 2008 Adolor ...
involved in the prescribing, dispensing, or administration of Entereg. ... Entereg can be used for no more than 15 doses in inpatients, and that Entereg is
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http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrug...
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FDA issues approvable letter for Entereg for POI
6 Nov 2006 ... “We continue to believe that Entereg has significant potential to benefit patients at risk of developing POI and those suffering from OBD ...
http://www.gsk.com/media/pressreleases/2006/2006_11_06_GSK92...
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Alvimopan (Entereg), a Peripherally Acting mu-Opioid Receptor ...
Meeting of the Gastrointestinal Drugs Advisory Committee to Evaluate Entereg ( Alvimopan) for the Acceleration of Recovery Time to Upper and Lower ...
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2730789/...
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Adolor's complete response to approvable letter for Entereg ...
31 May 2006 ... On July 21, 2005 the FDA issued an approvable letter for Entereg ® (alvimopan), an investigational drug under review for the management of ...
http://www.gsk.com/media/pressreleases/2006/2006_05_31_GSK84...
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ENTEREG® (ALVIMOPAN) - ADOLOR
20 May 2008 ... ENTEREG is a peripherally-acting mu opioid receptor (PAM-OR) antagonist designed to block the adverse side effects of opioid analgesics on ...
http://www.adolor.com/research/index.asp?page=entereg-alvimo...
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GlaxoSmithKline and Adolor report favourable FDA Advisory ...
23 Jan 2008 ... The FDA is reviewing Adolor's New Drug Application (NDA) for Entereg for the proposed indication of acceleration of upper and lower ...
http://www.gsk.com/media/pressreleases/2008/2008_pressreleas...
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Clinical Pharmacology & Therapeutics - Abstract of article ...
Alvimopan (enteregTM), a novel opioid antagonist, achieves active systemic concentrations. J. Foss MD1, V. Schmith PhD1, B. Wallin MD1, W. Du PhD1 and A.
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http://www.nature.com/clpt/journal/v77/n2/abs/clpt2005287a.h...
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