title: Efforts to support the development of fusidic acid in the United States.
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.
authors.affiliation: Cempra Pharmaceuticals, Chapel Hill, North Carolina, USA. prabha@fernandes-domain.com
authors.forename: Prabhavathi
authors.initials: P
authors.lastname: Fernandes
authors.forename: David
authors.initials: D
authors.lastname: Pereira
mesh_terms: D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000494:pharmacology; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D004345:Drug Industry; D005672:Fusidic Acid / Q000008:administration & dosage* / Q000009:adverse effects / Q000494:pharmacology; D006801:Humans; D040541:Marketing; D055624:Methicillin-Resistant Staphylococcus aureus / Q000187:drug effects*; D008826:Microbial Sensitivity Tests; D010330:Patents as Topic; D013203:Staphylococcal Infections / Q000188:drug therapy*; D013211:Staphylococcus aureus / Q000187:drug effects; D014481:United States
chemical_list: D000900:Anti-Bacterial Agents; D005672:Fusidic Acid