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List Of Upcoming (Oct – Nov 2012) FDA Advisory Committee Tentative Meetings Involving Orphan Drugs (Updated October 10, 2012)

September 14, 2012

       Here is a list of upcoming (Oct – Nov 2012) FDA Advisory Committee Tentative Meetings involving orphan drugs :

1) October 16, 2016: Gastrointestinal Drugs Advisory Committee Meeting to “discuss the safety & efficacy of new drug application (NDA) 203441, with the proposed trade name Gattex (teduglutide) for subcutaneous injection, by NPS Pharmaceuticals, Inc, for the proposed indication of treatment of adult patients with short bowel syndrome (SBS)” 

2) October 17, 2012: Endocrinologic & Metabolic Drugs Advisory Committee Meeting to “discuss new drug application (NDA) 203858, lomitapide capsules, by Aegerion Pharmaceticals, Inc. The proposed indication (use) is as an adjunct to a low-fat diet & other lipid-lowering drugs with or without LDL apheresis to reduce LDL cholesterol, total cholesterol, apolipoprotein B, and triglycerides in patients with homozygous familial hypercholesterolemia.” 

3)  October 18, 2012: Endocrinologic & Metabolic Drugs Advisory Committee Meeting to discuss “new drug application (NDA) 203568, mipomersen injection, by Genzyme Corporation. The proposed indication (use) is as an adjunct to maximally tolerated lipid-lowering medications and diet to reduce low-density lipoprotein (LDL) cholesterol, apolipoprotein B, total cholesterol, non-high density lipoprotein-cholesterol and lipoprotein (a) in patients with homozygous familial hypercholesterolemia.”

4)  November 2, 2012: Anti-Infective Drugs Advisory Committee Meeting to “discuss biologics licensing application (BLA) 125346, raxibacumab injection, a humanized monoclonal antibody against protective antigen of Bacillis anthracis, by Human Genome Sciences, Inc for the proposed indication of treatment of inhalational anthrax”.  

References 

FDA 2012 Advisory Committee Tentative Meetings as of 08/17/2012

FDA 2012 Advisory Committee Calendar as of 09/12/2012

FDA Orphan Drug Production Designation Database Application

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

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