Table 3.
Pharmacological and Chemical Classes | 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) |
---|---|---|---|---|---|---|
Aminoglycoside Antibacterials | 2 (2, 100.0%) | - | - | - | 1 (0, 0.0%) | 3 (2, 66.7%) |
Other aminoglycosides | 2 (2, 100.0%) | - | - | - | 1 (0, 0.0%) | 3 (2, 66.7%) |
Beta-Lactam Antibacterials, Penicillins | 7 (4, 57.1%) | 1 (0, 0.0%) | - | - | - | 8 (4, 50.0%) |
Combinations of penicillins, incl. beta-lactamase inhibitors | 2 (0, 0.0%) | 1 (0, 0.0%) | - | - | - | 3 (0, 0.0%) |
Penicillins with extended spectrum | 5 (4, 80.0%) | - | - | - | - | 5 (4, 80.0%) |
Macrolides, Lincosamides and Streptogramins | 2 (0, 0.0%) | 1 (1, 100.0%) | 2 (1, 50.0%) | - | - | 5 (2, 40.0%) |
Macrolides | 2 (0, 0.0%) | 1 (1, 100.0%) | 1 (1, 100.0%) | - | - | 4 (2, 50.0%) |
Streptogramins | - | - | 1 (0, 0.0%) | - | - | 1 (0, 0.0%) |
Other Antibacterials | - | 1 (0, 0.0%) | 3 (0, 0.0%) | 3 (0, 0.0%) | 2 (0, 0.0%) | 9 (0, 0.0%) |
Glycopeptide antibacterials | - | - | 1 (0, 0.0%) | 2 (0, 0.0%) | - | 3 (0, 0.0%) |
Imidazole derivatives | - | - | - | - | 1 (0, 0.0%) | 1 (0, 0.0%) |
Other antibacterials | - | 1 (0, 0.0%) | 2 (0, 0.0%) | 1 (0, 0.0%) | 1 (0, 0.0%) | 5 (0, 0.0%) |
Other Beta-Lactam Antibacterials | 20 (10, 50.0%) | 3 (1, 33.3%) | 5 (2, 40.0%) | 2 (0, 0.0%) | 3 (0, 0.0%) | 33 (13, 39.4%) |
Carbapenems | 1 (0, 0.0%) | 1 (0, 0.0%) | 2 (1, 50.0%) | - | 2 (0, 0.0%) | 6 (1, 16.7%) |
Fourth-generation cephalosporins | - | 1 (0, 0.0%) | - | - | - | 1 (0, 0.0%) |
Monobactams | 1 (0, 0.0%) | - | - | - | - | 1 (0, 0.0%) |
Other cephalosporins and penems | - | - | 1 (0, 0.0%) | 1 (0, 0.0%) | 1 (0, 0.0%) | 3 (0, 0.0%) |
Second-generation cephalosporins | 8 (5, 62.5%) | - | - | - | - | 8 (5, 62.5%) |
Third-generation cephalosporins | 10 (5, 50.0%) | 1 (1, 100.0%) | 2 (1, 50.0%) | 1 (0, 0.0%) | - | 14 (7, 50.0%) |
Quinolone Antibacterials | 7 (5, 71.4%) | 2 (2, 100.0%) | 5 (4, 80.0%) | - | 1 (0, 0.0%) | 15 (11, 73.3%) |
Fluoroquinolones | 6 (4, 66.7%) | 2 (2, 100.0%) | 5 (4, 80.0%) | - | 1 (0, 0.0%) | 14 (10, 71.4%) |
Other quinolones | 1 (1, 100.0%) | - | - | - | - | 1 (1, 100.0%) |
Tetracyclines | - | - | 1 (0, 0.0%) | - | 3 (0, 0.0%) | 4 (0, 0.0%) |
Tetracyclines | - | - | 1 (0, 0.0%) | - | 3 (0, 0.0%) | 4 (0, 0.0%) |
Total | 38 (21, 55.3%) | 8 (4, 50.0%) | 16 (7, 43.8%) | 5 (0, 0.0%) | 10 (0, 0.0%) | 77 (32, 41.6%) |
FDA approved systemic antibiotics (annual average of discontinuations; discontinuations as percentage of total approvals).