Table 1.
Novel therapeutics and associated indications approved by the Food and Drug Administration between 2005 and 2012.
| Novel Therapeutics (n=188) | |
| Approval Year | |
| 2005 | 19 (10.1) |
| 2006 | 22 (11.7) |
| 2007 | 17 (9.0) |
| 2008 | 20 (10.6) |
| 2009 | 25 (13.3) |
| 2010 | 20 (10.6) |
| 2011 | 28 (14.9) |
| 2012 | 37 (19.7) |
| Review Cycles Required for Approval | |
| Single | 134 (71.3) |
| Multiple | 54 (28.7) |
| Novel Therapeutic Type | |
| Pharmacologic | 154 (81.9) |
| Biologic | 34 (18.1) |
| Orphan Status | |
| Orphan designation | 31 (16.5) |
| No orphan designation | 157 (83.5) |
| Accelerated Approval | |
| Accelerated approval | 22 (11.7) |
| Regular approval | 166 (88.3) |
| Associated Indications (n=206) | |
| Therapeutic Area | |
| Cancer | 41 (19.9) |
| Infectious disease | 29 (14.1) |
| Cardiovascular disease, diabetes mellitus and hyperlipidemia | 23 (11.2) |
| Neurologic | 17 (8.3) |
| Dermatologic | 15 (7.3) |
| Autoimmune and musculoskeletal | 13 (6.3) |
| Psychiatric | 10 (4.9) |
| Other | 58 (28.2) |
| Expected Length of Treatment | |
| Acute | 40 (19.4) |
| Intermediate | 58 (28.2) |
| Chronic | 108 (52.4) |