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. 2023 Jun 15;11(12):1759. doi: 10.3390/healthcare11121759

Table 3.

FDA approvals, discontinuations, and percentage of market discontinuations of new systemic antibiotics by pharmacological and chemical classes, 1980–2021.

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).

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