Pediatric-specific indication and child-friendly, age-appropriate oral dosage forms for new drugs, by therapeutic drug class
| Therapeutic class | No. (%) of NASs | ||||
|---|---|---|---|---|---|
| Approved n = 270 | Pediatric indication (all)* | Nonbiologics approved, n = 198 | Pediatric indication (nonbiologic)† | Child-friendly oral dosage form‡ | |
| Oncology | 57 (21.1) | 4/57(7.0) | 39 (19.6) | 1/39 (2.4) | 0 |
| Infectious disease | 39 (14.4) | 18/39 (46.1) | 33 (16.6) | 12/33 (36.2) | 3/21 (14.2) |
| Hematology | 26 (9.6) | 11/26 (42.3) | 12 (6.0) | 2/12 (16.5) | 1/10 (10.0) |
| Endocrine or metabolic | 24 (8.8) | 10/24 (41.6) | 16 (8.0) | 4/16 (25.0) | 3/13 (23.0) |
| Cardiology | 20(7.4) | 3/20 (15.0) | 17 (8.4) | 2/17 (11.6) | 1/15 (6.6) |
| Allergy or immunology | 17 (6.2) | 10/17 (58.8) | 4 (2.0) | 1/4 (25.0) | 1/3 (33.3) |
| Neurology | 15 (5.6) | 4/15 (26.6) | 14 (7.0) | 4/14 (28.9) | 3/10 (30.0) |
| Pulmonology | 15 (5.6) | 5/15 (33.3) | 13 (6.4) | 5/13 (38.3) | 1/6 (16.6) |
| Gastrointestinal | 12 (4.4) | 3/12 (25.0) | 11 (5.6) | 2/11 (18.2) | 1/8 (12.5) |
| Ophthalmology | 10 (3.7) | 2/10 (20.0) | 8 (4.0) | 2/8 (25.0) | 0 |
| Psychiatry | 10 (3.7) | 2/10 (20.0) | 10 (5.0) | 2/10 (20.0) | 0 |
| Rheumatology | 8 (2.9) | 1/8 (12.5) | 4 (2.0) | 0 | 0 |
| Obstetrics or gynecology | 5 (1.8) | 1/3 (33.3) | 3 (1.5) | 1/3 (33.4) | 0 |
| Anesthesia or analgesia | 3 (1.1) | 0 | 3 (1.5) | 0 | 0 |
| Dermatology | 3 (1.1) | 0 | 3 (1.5) | 0 | 0 |
| Diagnostic imaging | 3 (1.1) | 1/3 (33.4) | 3 (1.5) | 1/3 (33.4) | 0 |
| Urology | 3 (1.1) | 0 | 3 (1.5) | 0 | 0 |
| Nephrology | 2 (0.7) | 1/2 (50.0) | 2 (1.0) | 1/2 (50.0) | 1/2 (50.0) |
| Toxicology | 0 | 0 | 0 | 0 | 0 |
| Total | 270 | 75 | 198 | 40 | 15 |