U.S. flag An official website of the United States government
  1. Home
  2. Drugs
  3. Development & Approval Process | Drugs
  4. Development Resources
  5. Pediatric Exclusivity Statistics
  1. Development Resources

Pediatric Exclusivity Statistics

Printable Excel File (XLS - 38 KB)

As of August 1, 2019

Review Division
 
Proposed Pediatric Study Requests (PPSRs) Received * Written Requests Issued
DCRP (Division of Cardiovascular Renal Products) 89 50
DNP (Division of Neurology Products) 85 40
DPP (Division of Psychiatry Products) 67
Updated
47
DOP1 (Division of Oncology Products 1) 36
Updated
21
DOP2 (Division of Oncology Products 2) 61
Updated
35
DHP (Division of Hematology Products) 105
Updated
40
40DMIP (Division of Medical Imaging Products ) 14 7
DAAAP (Division of Analgesia, Anesthesia and Addiction Products) 80 40
DGIEP (Division of Gastroentereology and Inborn Products) 77 29
DMEP (Division of Metabolism and Endocrinology Products) 148
Updated
53
Updated
DAIP (Division of Anti-Infective Products) 29
Updated
11
DAVP (Division of Anti-Viral Products) 70
Updated
54
DDDP (Division of Dermatology and Dental Products) 64
Updated
26
DNDP (Division of Nonprescription Drug Products) 10 5
DPARP (Division of Pulmonary, Allergy and Rheumatology Products) 65 34
DBRUP (Division of Bone, Reproductive and Urologic Products) 37 14
DTOP (Division of Transplant and Ophthalmology Products) 42 54
TOTAL 1078
Updated
561
Updated

Back to Top

Numbers reflect the number of drugs (i.e., active moiety) per division.

Written Requests with PPSRs - 481

Updated

Written Requests without PPSRs 80  
Incomplete Responses - 544

Updated

PPSR Withdrawals - 32
Written Request Withdrawals - 10
Written Request Amendments - 660

Updated

TOTAL ACTIONS = 1808

Updated

*This column will never equal the number of proposals submitted, because a Written Request may be issued without a proposal, and a proposal may result in an action that is incomplete instead of a Written Request.

*New/Transfers/Miscodes- some PPSRs were transferred to other divisions or deleted due to miscodes. The PPSRs are organized by therapeutic area within the Pediatric Exclusivity database.

Back to Top