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Clin Infect Dis. 2011 Jun;52 Suppl 7:S542-6. doi: 10.1093/cid/cir170.

Efforts to support the development of fusidic acid in the United States.

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1
Cempra Pharmaceuticals, Chapel Hill, North Carolina, USA. prabha@fernandes-domain.com

Abstract

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.

PMID:
21546632
DOI:
10.1093/cid/cir170
[Indexed for MEDLINE]
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