Pediatric Exclusivity Statistics

Printable Excel File (XLS - 39 KB)

As of March 1, 2019

Review Division
Proposed Pediatric Study Requests (PPSRs) Received* Written Requests Issued
DCRP (Division of Cardiovascular Renal Products)8950
DNP (Division of Neurology Products)8240
DPP (Division of Psychiatry Products)63 47
DOP1 (Division of Oncology Products 1)3421
DOP2 (Division of Oncology Products 2)5932
DHP (Division of Hematology Products)9840 Updated
DMIP (Division of Medical Imaging Products )147
DAAAP (Division of Analgesia, Anesthesia and Addiction Products)8040
DGIEP (Division of Gastroentereology and Inborn Products)7728
DMEP (Division of Metabolism and Endocrinology Products)14049 Updated
DAIP (Division of Anti-Infective Products)3311
DAVP (Division of Anti-Viral Products)6854
DDDP (Division of Dermatology and Dental Products)63Updated26
DNDP (Division of Nonprescription Drug Products)105
DPARP (Division of Pulmonary, Allergy and Rheumatology Products)65 Updated34
DBRUP (Division of Bone, Reproductive and Urologic Products)3714
DTOP (Division of Transplant and Ophthalmology Products)4254
TOTAL1053 Updated552 Updated

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

Written Requests with PPSRs - 472 Updated 
Written Requests without PPSRs 80  
Incomplete Responses - 528 Updated
PPSR Withdrawals - 32
Written Request Withdrawals - 10
Written Request Amendments - 650 Updated
TOTAL ACTIONS = 1772 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.

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Page Last Updated: 04/12/2019
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