Table 2.
Market discontinuations of FDA-approved drugs by therapeutic class, 1980–2021.
| Therapeutic Class | 1980–PDUFA (1992) | PDUFA (1992)–FDAMA (1997) | FDAMA (1997)–FDASIA (2012) | FDASIA (2012)–21st Century Cures Act (2016) | 21st Century Cures Act (2016)–2021 | Total (1981–2021) |
|---|---|---|---|---|---|---|
| Antineoplastic and Immunomodulating Agents | 7 (0.5, 2.4%) | - | 8 (0.5, 2.0%) | 2 (0.5, 1.2%) | 3 (0.6, 1.1%) | 20 (0.5, 1.5%) |
| Nervous System | 5 (0.4, 1.7%) | 2 (0.4, 1.1%) | 2 (0.1, 0.5%) | - | - | 9 (0.2, 0.7%) |
| Alimentary Tract and Metabolism | 2 (0.2, 0.7%) | 3 (0.6, 1.7%) | 5 (0.3, 1.2%) | 2 (0.5, 1.2%) | - | 12 (0.3, 0.9%) |
| Cardiovascular System | 12 (0.9, 4.1%) | 5 (1.0, 2.8%) | 2 (0.1, 0.5%) | 1 (0.2, 0.6%) | - | 20 (0.5, 1.5%) |
| Diagnostic drugs | 14 (1.1, 4.7%) | 11 (2.2, 6.1%) | 7 (0.5, 1.7%) | - | - | 32 (0.8, 2.4%) |
| Antibacterials for Systemic Use | 21 (1.6, 7.1%) | 4 (0.8, 2.2%) | 7 (0.5, 1.7%) | - | - | 32 (0.8, 2.4%) |
| Antivirals for Systemic Use | 3 (0.2, 1.0%) | 5 (1.0, 2.8%) | 5 (0.3, 1.2%) | 3 (0.7, 1.9%) | - | 16 (0.4, 1.2%) |
| Blood and Blood Forming Organs | 1 (0.1, 0.3%) | 4 (0.8, 2.2%) | 5 (0.3, 1.2%) | - | 1 (0.2, 0.4%) | 11 (0.3, 0.8%) |
| Musculo-Skeletal System | 7 (0.5, 2.4%) | 2 (0.4, 1.1%) | 3 (0.2, 0.7%) | 1 (0.2, 0.6%) | - | 13 (0.3, 1.0%) |
| Dermatologicals | 3 (0.2, 1.0%) | - | 3 (0.2, 0.7%) | - | - | 6 (0.1, 0.5%) |
| Respiratory System | 5 (0.4, 1.7%) | 1 (0.2, 0.6%) | 2 (0.1, 0.5%) | - | - | 8 (0.2, 0.6%) |
| Sensory Organs | 2 (0.2, 0.7%) | 2 (0.4, 1.1%) | 5 (0.3, 1.2%) | 2 (0.5, 1.2%) | - | 11 (0.3, 0.8%) |
| Genito Urinary System and Sex Hormones | 1 (0.1, 0.3%) | - | - | - | - | 1 (0.0, 0.1%) |
| Antiparasitic Products, Insecticides and Repellents | 5 (0.4, 1.7%) | 1 (0.2, 0.6%) | 1 (0.1, 0.2%) | - | 1 (0.2, 0.4%) | 8 (0.2, 0.6%) |
| Systemic Hormonal Preparations, Excluding Sex Hormones and Insulins | 3 (0.2, 1.0%) | - | 1 (0.1, 0.2%) | - | - | 4 (0.1, 0.3%) |
| Other Antiinfectives for Systemic Use | 1 (0.1, 0.3%) | - | 0 (0.0, 0.0%) | - | - | 1 (0.0, 0.1%) |
| All Other Therapeutic Products | 2 (0.2, 0.7%) | 1 (0.2, 0.6%) | 3 (0.2, 0.7%) | - | - | 6 (0.1, 0.5%) |
| Total | 94 (7.3, 31.9%) | 41 (8.1, 22.8%) | 59 (4.0, 14.5%) | 11 (2.5, 6.8%) | 5 (1.0, 1.9%) | 210 (5.0, 16.0%) |
Drug discontinuations by regulatory period (annual average of discontinuations; discontinuations as percentage of total approvals).