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Table 1 Characteristics of 61 new drugs and biologics approved by the US Food and Drug Administration from 2009 through 2012 with at least one postmarketing commitment

From: Postmarketing commitments for novel drugs and biologics approved by the US Food and Drug Administration: a cross-sectional analysis

Characteristic No. (%)
Drugs
N = 39
Biologics
N = 22
Total
N = 61
Approval year
 2009 9 (23.1) 6 (27.3) 15 (24.6)
 2010 8 (20.5) 4 (18.2) 12 (19.7)
 2011 12 (30.8) 6 (27.3) 18 (29.5)
 2012 10 (25.6) 6 (27.3) 16 (26.2)
Therapeutic area
 Cancer and hematology 12 (30.8) 7 (31.8) 19 (31.2)
 Infectious disease 6 (15.4) 0 (0.0) 6 (9.8)
 Cardiovascular, diabetes, and hyperlipidemia 2 (5.1) 0 (0.0) 2 (3.3)
 Autoimmune, musculoskeletal, and dermatology 2 (5.1) 9 (40.9) 11 (18.0)
 Neurology and psychiatry 7 (17.9) 0 (0.0) 7 (11.5)
 Respiratory 2 (5.1) 0 (0.0) 2 (3.3)
 Gastrointestinal 2 (5.1) 0 (0.0) 2 (3.3)
 Rare/metabolic diseases 3 (7.7) 1 (4.5) 4 (6.6)
 Othera 3 (7.7) 5 (22.7) 8 (13.2)
Priority review
 Yes 21 (53.8) 0 (0.0) 21 (34.4)
 No 18 (46.2) 22 (100.0) 40 (65.6)
Accelerated approval
 Yes 5 (12.8) 2 (9.1) 7 (11.5)
 No 34 (87.2) 20 (90.9) 54 (88.5)
Orphan Drug Designation
 Yes 10 (25.6) 4 (18.2) 14 (23.0)
 No 29 (74.4) 18 (81.8) 47 (77.0)
  1. a“Other” includes contraception, hyponatremia, ophthalmology, and thalassemia syndromes