Graul A I, Cruces E, Dulsat C, Arias E, Stringer M
Thomson Reuters, Barcelona, Spain.
Drugs Today (Barc). 2012 Jan;48(1):33-77. doi: 10.1358/dot.2012.48.1.1769676.
2011 was a good year in many respects for the pharmaceutical industry, especially regarding the approval and launch of several important new products. The FDA reported a record high rate of approvals during FY2011 (October 1, 2010-September 30, 2011), reflecting the agency's commitment to maintaining "a state-of-the-art drug approval process that brings important drugs to market quickly and efficiently" (1). While not all of the new drugs and biologics listed in FDA's fiscal year summary meet the criteria for inclusion in this article, most of them do, and hence are reviewed in the following pages. Also covered in this year's expanded article are new approvals and new launches in other global markets, line extensions and other developments of interest to the industry: generic drug approvals, product withdrawals and discontinuations, new developments in the area of orphan drugs and diseases, and more.
2011年在许多方面对制药行业来说是不错的一年，尤其是在几款重要新产品的获批和上市方面。美国食品药品监督管理局（FDA）报告称，2011财年（2010年10月1日至2011年9月30日）的获批率创下历史新高，这反映了该机构致力于维持“一个将重要药物快速且高效地推向市场的先进药品审批流程”（1）。虽然FDA财年总结中列出的并非所有新药和生物制品都符合纳入本文的标准，但其中大多数符合，因此在接下来的页面中会对它们进行回顾。今年扩充后的文章还涵盖了其他全球市场的新获批和新上市产品、产品线延伸以及该行业感兴趣的其他发展情况：仿制药获批、产品撤市和停产、孤儿药及相关疾病领域的新进展等等。
