This annual article presents new drugs and biologics that were launched or approved for the first time during the previous year. In 2009, 51 new medicines and vaccines reached their first markets. Line extensions (new indications, new formulations and new combinations of previously marketed products) accounted for more than 30% of the new products launched in 2009. In addition to providing an overview of all drugs and biologics launched or approved for the first time ever in the previous year, this article will also review in further depth the first-in-class drugs launched for the first time last year, providing a better understanding of their novel mechanisms of action; an analysis of the discovery and development periods for the year's new products; and a comprehensive overview of drug repositioning as a strategy for extending the life spans of medicines. We also provide a brief glimpse at selected drugs and biologics which could reach their first markets in the foreseeable future.

This annual article presents new drugs and biologics that were launched or approved for the first time during the previous year. In 2008, 31 new medicines-this figure includes both drugs and biologics for therapeutic use as well as new diagnostic agents-reached their first markets. Line extensions (new indications, new formulations and new combinations of previously marketed products) accounted for more than one-third of the new medicines launched in 2008. In addition to providing an overview of all drugs and biologics launched or approved for the first time ever in the previous year, this article will also review in further depth the first-in-class drugs launched for the first time last year, providing a better understanding of their novel mechanisms of action; an analysis of the discovery and development periods for the year's new products; and a comprehensive overview of drug repositioning as a strategy for extending the life spans of medicines. We also provide a brief glimpse at selected drugs and biologics which could reach their first markets in the foreseeable future.

The year 2010 marked the first launch for a number of new drugs and biologics, including several important innovations and therapeutic advances. Twenty-nine new chemical entities and biologics for therapeutic use reached their first markets in 2010. Following a growing tendency in recent years, at least 20 important line extensions were also introduced last year. Both figures are significantly lower than those registered in 2009. Pharma and biotech companies also became leaner and more competitive in 2010 through two processes: prioritizing R&D and discontinuing less promising projects, and merging with or acquiring companies with complementary strengths and weaknesses. This review provides a brief overview of the highlights of 2010.

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.

In the face of patent expirations on blockbuster drugs and declining innovation in the industry, pharma/biotech companies are restructuring their research and development operations and are pursuing an aggressive strategy of acquisitions, licensing deals and research collaborations in an attempt to fill the gaps in their product pipelines.