Cempra Pharmaceuticals, Chapel Hill, North Carolina, USA.
Clin Infect Dis. 2011 Jun;52 Suppl 7:S542-6. doi: 10.1093/cid/cir170.
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.
夫西地酸（FA）虽然在全球范围内广泛使用了几十年，但从未在美国获得批准。现在非常需要一种具有长期安全记录的口服耐甲氧西林金黄色葡萄球菌（MRSA）抗生素。Cempra 制药公司成功地鼓励通过了一项国会修正案，当这种抗生素在美国获得批准时，允许按照《 Hatch-Waxman 法案》享有市场独占权。一种新的剂量方案已获得专利，允许 FA 作为单药治疗使用，并且已经显示出降低了耐药选择性。由于在美国对 FA 的耐药性几乎为零，因此现在正是将其引入该市场的好时机。
