Table 2.
Characteristics of new therapeutics approved by Food and Drug Administration, 1987-2014
| Characteristics | No (%)* |
|---|---|
| Therapeutic area: | |
| Infectious disease | 109 (14) |
| Oncology | 107 (14) |
| Cardiovascular disease and its risk factors† | 99 (13) |
| Neuropsychiatry | 97 (13) |
| Musculoskeletal disease and immunomodulators | 80 (10) |
| Gastroenterology | 58 (7) |
| Hematology | 43 (6) |
| Allergy and pulmonology | 35 (5) |
| Ophthalmology | 34 (4) |
| Dermatology | 31 (4) |
| Endocrinology | 25 (3) |
| Genitourinary disease | 19 (2) |
| Other | 37 (5) |
| Expedited programs: | |
| Orphan drug | 195 (25) |
| Fast track | 144 (19) |
| Accelerated approval | 68 (9) |
| Priority review | 331 (43) |
| Innovativeness‡ | |
| First in class drug | 252 (33) |
| Non-first in class drug | 508 (67) |
*Total of 774 approved therapeutics in our database.
†Including diabetes mellitus, hyperlipidemia, and hypertension.
‡FDA classification available for 760 of these therapeutics.