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Efforts to support the development of fusidic Acid in the United States.
MedLine Citation:
PMID:  21546632     Owner:  NLM     Status:  In-Data-Review    
Abstract/OtherAbstract:
Fusidic acid (FA), though used widely throughout the world for decades, has never been approved in the United States. There is now a great need for an oral methicillin-resistant Staphylococcus aureus (MRSA) antibiotic with a long track record of safety. Cempra Pharmaceuticals successfully encouraged passage of a congressional amendment to allow for Hatch-Waxman market exclusivity when this antibiotic is approved in the United States. A new dosing regimen has been patented, allowing FA to be used as monotherapy, and decreased resistance selectivity has been shown. With almost no resistance to FA in the United States, the time is right for introduction into this market.
Authors:
Prabhavathi Fernandes; David Pereira
Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Clinical infectious diseases : an official publication of the Infectious Diseases Society of America     Volume:  52 Suppl 7     ISSN:  1537-6591     ISO Abbreviation:  Clin. Infect. Dis.     Publication Date:  2011 Jun 
Date Detail:
Created Date:  2011-05-06     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9203213     Medline TA:  Clin Infect Dis     Country:  United States    
Other Details:
Languages:  eng     Pagination:  S542-6     Citation Subset:  IM    
Affiliation:
Cempra Pharmaceuticals, Chapel Hill, North Carolina.
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