Table 1 Characteristics of 61 new drugs and biologics approved by the US Food and Drug Administration from 2009 through 2012 with at least one postmarketing commitment
Characteristic | No. (%) | ||
|---|---|---|---|
Drugs N = 39 | Biologics N = 22 | Total N = 61 | |
Approval year | |||
2009 | 9 (23.1) | 6 (27.3) | 15 (24.6) |
2010 | 8 (20.5) | 4 (18.2) | 12 (19.7) |
2011 | 12 (30.8) | 6 (27.3) | 18 (29.5) |
2012 | 10 (25.6) | 6 (27.3) | 16 (26.2) |
Therapeutic area | |||
Cancer and hematology | 12 (30.8) | 7 (31.8) | 19 (31.2) |
Infectious disease | 6 (15.4) | 0 (0.0) | 6 (9.8) |
Cardiovascular, diabetes, and hyperlipidemia | 2 (5.1) | 0 (0.0) | 2 (3.3) |
Autoimmune, musculoskeletal, and dermatology | 2 (5.1) | 9 (40.9) | 11 (18.0) |
Neurology and psychiatry | 7 (17.9) | 0 (0.0) | 7 (11.5) |
Respiratory | 2 (5.1) | 0 (0.0) | 2 (3.3) |
Gastrointestinal | 2 (5.1) | 0 (0.0) | 2 (3.3) |
Rare/metabolic diseases | 3 (7.7) | 1 (4.5) | 4 (6.6) |
Othera | 3 (7.7) | 5 (22.7) | 8 (13.2) |
Priority review | |||
Yes | 21 (53.8) | 0 (0.0) | 21 (34.4) |
No | 18 (46.2) | 22 (100.0) | 40 (65.6) |
Accelerated approval | |||
Yes | 5 (12.8) | 2 (9.1) | 7 (11.5) |
No | 34 (87.2) | 20 (90.9) | 54 (88.5) |
Orphan Drug Designation | |||
Yes | 10 (25.6) | 4 (18.2) | 14 (23.0) |
No | 29 (74.4) | 18 (81.8) | 47 (77.0) |