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NPS Pharmaceuticals’ Orphan Drug Gattex And The Release Of FDA Briefing Documents: Perspective

October 14, 2012

       An October 12, 2012 article reviews and analyzes the release of the FDA briefing documents for the October 16, 2012, FDA Advisory Committee review of NPS Pharmaceuticals’ orphan drug Gattex for Short Bowel Syndrome (SBS). Efficacy, safety, and the Risk Evaluation and Mediation (REMS) plan are evaluated.  

        Per, “Based on the briefing documents, it appears that the FDA has already answered its own questions and much made up its mind on approving Gattex. Going into Tuesday’s panel, I would not be surprised to see a unanimous positive vote, with the FDA approving the drug before Thanksgiving, more than a month ahead of the December 30th PDUFA date …..”.  

Copyright  © 2012-2013, Ann-Teresa Cusenza and Orphan Druganaut Blog.  All rights reserved.


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