Resumen de The Year's New Drug & Biologics, 2011
Ann I. Graul, Elisabet Cruces, Coia Dulsat, E. Arias, Mark Stringer
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.
