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November 2012 FDA Advisory Committee Meetings Involving Orphan Drugs

November 7, 2012

       Here is a list of November 2012 FDA Advisory Committee (AdComm) Meetings involving orphan drugs (Please contact the Orphan Druganaut Blog if the reader is aware of any updates) : 

1) 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 Bascillis anthracis, by Human Genome Sciences, Inc. for the proposed indication of treatment of inhalational anthrax.” 

Meeting Materials  

2)  November 7, 2012: Endocrinologic and Metabolic Drugs Advisory Committee Meeting to “discuss the safety and efficacy of a new drug application (NDA) 200677, pasireotide injection (proposed trade name SIGNIFOR) for subcutaneous administration, submitted by Novartis Pharmaceuticals Corporation. Pasireotide is an analog (a chemical compound that resembles another compound in structure) of somatostatin. The proposed indication (use) for pasireotide injection is the treatment of patients with Cushing’s Disease who require medical intervention …”. 

Meeting Materials 

3)  November 28, 2012: Anti-Infective Drugs Advisory Committee Meeting to discuss “the safety & effectiveness of new drug application (NDA) 204384, bedaquiline tablets, submitted by Janssen Therapeutics, Division of Janssen Products, LP. The proposed indication (use) for this product is for the treatment of patients with multi-drug resistant pulmonary tuberculosis”. 

References 

FDA 2012 Advisory Committee Tentative Meetings as of 10/10/2012  

FDA 2012 Advisory Committee Calendar as of 11/07/2012  

Copyright © 2012-2013, Orphan Druganaut Blog.  All rights reserved.

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