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. 2014 Jan;50(1):51-100.
doi: 10.1358/dot.2014.50.1.2116673.

The year's new drugs & biologics, 2013: Part I

A I Graul  1 , E Cruces  2 , M Stringer  2
Affiliations

The year's new drugs & biologics, 2013: Part I

A I Graul et al. Drugs Today (Barc). 2014 Jan.

Abstract

This article provides a comprehensive overview of the 56 new drugs and biologics introduced for the first time in 2013, the largest number in at least a decade. This includes 20 new orphan drugs and 10 first-in-class agents, as well as the first three products bearing the FDA's new Breakthrough Therapy Designation. The review also covers 30 important new line extensions, encompassing new indications, new formulations and new combinations of previously marketed agents. In addition to this bumper crop of new launches, another 19 products were approved for the first time during the year but not yet launched by the close of this article; these new products are also discussed.

Keywords: Line extensions; New approvals; New biologics; New drug launches; Orphan drugs.

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