Pediatric Exclusivity Statistics
Printable Excel File (XLS - 38 KB)
As of October 1, 2019
| Review Division |
Proposed Pediatric Study Requests (PPSRs) Received | * Written Requests Issued |
|---|---|---|
| DCRP (Division of Cardiovascular Renal Products) | 90
|
50 |
| DNP (Division of Neurology Products) | 86 | 40 |
| DPP (Division of Psychiatry Products) | 66 | 47 |
| DOP1 (Division of Oncology Products 1) | 36 | 21 |
| DOP2 (Division of Oncology Products 2) | 61 | 35 |
| DHP (Division of Hematology Products) | 108
|
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) | 78 | 29 |
| DMEP (Division of Metabolism and Endocrinology Products) | 148 | 53 |
| DAIP (Division of Anti-Infective Products) | 29 | 11 |
| DAVP (Division of Anti-Viral Products) | 70 | 54 |
| DDDP (Division of Dermatology and Dental Products) | 65
|
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 | 1084
|
561 |
Numbers reflect the number of drugs (i.e., active moiety) per division.
Written Requests with PPSRs - 481
Written Requests without PPSRs 80
Incomplete Responses - 550
PPSR Withdrawals - 33
Written Request Withdrawals - 10
Written Request Amendments - 666
TOTAL ACTIONS = 1820
*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.